Shiftkey Llc Jobs in Usa

Our client a global retail brand, is seeking a highly organized and detail-oriented Team Leader to support daily warehouse operations. The ideal candidate will have strong leadership qualities and the ability to analyze and resolve inventory issues efficiently. This role is key in maintaining stock accuracy and ensuring smooth order fulfillment.

Job Duties Include:

• Lead and supervise staff in various warehouse functions, including picking, packing, and shipping
• Assist in training and onboarding new employees on standard operating procedures
• Perform daily quality checks on shipped orders to ensure accuracy and compliance
• Enter inventory movement data into the SAP system
• Identify and resolve inventory-related issues and discrepancies
• Handle customer returns in a timely and efficient manner
• Share inventory updates and reports with warehouse internal teams and management
• Conduct regular inventory cycle counts to ensure data accuracy
• Oversee receiving, stock placement, and consolidation processes
• Additional duties as needed and assigned

Job Qualifications Include:

• A high school diploma or GED is required for this role
• Excellent organizational skills with the ability to prioritize tasks effectively
• High attention to detail and commitment to accuracy in all areas of work
• Proficiency in warehouse management systems (WMS), handheld RF scanners.
• Advanced Microsoft Excel is required, including the use of formulas, pivot tables, and data analysis tools.
• Strong analytical and decision-making abilities
• Clear and confident communication skills with the ability to lead and motivate a team
• Proven experience managing daily warehouse operations and delegating tasks
• Skilled at evaluating and interpreting incomplete or unclear data to make informed and effective decisions.
• Experience operating a pallet jack and ability to lift up to 50lbs
• Ability to walk, stand and or sit for duration of shift

Compensation: $60k/yr

This is a temporary position. The worker will be employed and paid by PCG.

Benefits: Temporary employees through PCG may be eligible benefits after a waiting period, such as health insurance, dental and vision plans, paid holidays, and participation in our incentive savings program. Additional benefits may apply based on assignment and eligibility.

This role is assigned to a client company that may provide additional amenities or benefits to their internal staff. These may not apply to temporary assignments.

While PCG appreciates all applicants, only those qualified will be contacted. Thank you for your application. We look forward to hearing from you!

**PCG, in good faith, believes that this posted range of compensation is the accurate range for this role at this location at the time of this posting. PCG and our clients may ultimately pay more or less than the posted range depending on candidate qualifications. This range may be modified in the future.

Pyramid Consulting Group, LLC is an Equal Opportunity Employer that takes pride in a diverse environment. We do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status.

Please refer to our website: for access to our Right to Work and E-Verify Participation Posters.

Our client, a luxury fashion brand, is seeking a Luxury Client Service Advisor to join their office in Central New Jersey. Candidates should have a passion for client service, and experience engaging with clients remotely. In this role, you’ll create exceptional experiences for clients, build lasting relationships, and inspire brand loyalty while driving business results.

Job Responsibilities

• Deliver an elevated client experience through warm, professional, and personalized service
• Provide full-spectrum customer support via email and phone
• Facilitate online sales, deliveries, returns, and provide timely information to clients
• Coordinate with physical stores to ensure optimal customer experience
• Additional duties as needed and assigned

Role Qualifications

• 3+ years of experience in luxury brands or client-facing roles
• High school diploma or equivalent
• Strong communication skills and ability to connect with individuals quickly and meaningfully
• Team-oriented mindset with excellent problem-solving and multitasking abilities
• Flexible schedule, including evenings, weekends, and holidays
• Foreign language skills are a plus

Salary: $30/hr

The description above is intended to describe the general nature and level of work being performed and is not an exhaustive list of all duties, responsibilities, and qualifications required.

While PCG appreciates all applicants, only those qualified will be contacted. Thank you for your application. We look forward to hearing from you!

If you believe you are a great candidate for this position, and the salary listed does not meet your expectations, we would still love to speak to you! PCG, in good faith, believes that this posted range of compensation is the accurate range for this role at this location at the time of this posting. PCG and our clients may ultimately pay more or less than the posted range depending on candidate qualifications. This range may be modified in the future. This role may also be eligible for additional compensation including incentive pay, discretionary bonuses, and a comprehensive benefits package, details of which will be provided during the hiring process.

Pyramid Consulting Group, LLC is an Equal Opportunity Employer that takes pride in a diverse environment. We provide equal employment opportunities to all applicants and employees without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, marital or veteran status, disability, genetic information, or any other protected status under applicable law.

We will provide reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation during the application or hiring process, please contact

For positions subject to “Fair Chance” laws (including but not limited to California, Colorado, New York City, Los Angeles, and other jurisdictions), PCG will consider qualified applicants with arrest and conviction records in a manner consistent with applicable law.

Please refer to our website: for access to our Right to Work and E-Verify.

Job Title: Customer Success Manager

Location: US - Remote

OptymEdge is advancing global ophthalmology clinical trials through the Acuvera Suite-Certify, Capture, and Imaging-bringing digital transformation to visual function endpoints. To support this growth, we are seeking a Customer Success & Strategic Growth Manager to support and execute value realization, strengthen sponsor and CRO partnerships, and unlock long-term account expansion.

Primary Purpose

This client-facing role blends customer success, strategic account management, and commercial insight. You will partner with key global sponsors, oversee engagement across the customer lifecycle, and convert operational excellence into deeper, multi-service relationships. You will also contribute to the development of scalable CS frameworks that support OptymEdge's growth trajectory.

1. Strategic Account Leadership

* Serve as the primary point of contact for assigned strategic accounts

* Lead onboarding, adoption, and continuous value delivery across Certify, Capture, and Imaging modules

* Conduct structured governance meetings, QBRs, and planning sessions with client stakeholders

* Build multi-level, trust-based relationships anchored in scientific credibility and shared goals

* Identify risks early and drive cross-functional resolution to maintain delivery excellence

2. Growth & Expansion Opportunities

* Identify upsell, cross-sell, and multi-service expansion opportunities in partnership with Commercial and Business Development teams

* Contribute to the development of long-term partnership and account growth strategies

* Partner with Business Development on renewals, pricing input, and proposal development

* Track and report NRR, account health indicators, and expansion pipeline activity

3. Cross-Functional Partnership

* Collaborate with Delivery, Clinical, Product, Technology, and Marketing teams to ensure consistent execution

* Translate customer insights into actionable product and service improvement recommendations

* Contribute to value stories, case studies, and customer success narratives

* Serve as the internal voice of the customer to support alignment across teams

4. Operational Excellence & Scaling

* Contribute to the development and refinement of scalable CS processes, playbooks, and engagement frameworks

* Build and maintain account health models and standardized reporting dashboards

* Leverage CRM and analytics tools for forecasting, engagement tracking, and risk signaling

* Support knowledge sharing and onboarding activities as the CS function grows

* Bachelor's/Master's in Life Sciences, Business, or related field.

* 5+ years in customer success, strategic account management, or clinical operations.

* Experience with eClinical or digital health systems.

* Strong communication, stakeholder management, and commercial awareness

Bonus Points

* Experience in ophthalmology clinical research or endpoint services

* Familiarity with eSource, imaging, or certification platforms

* Experience in growth-stage or transformation-focused organizations

* Proficiency with Salesforce or similar CRM platforms

Emmes Group: Building a better future for us all.

OptymEdge is part of the The Emmes Group. Emmes is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Biostatistician

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, performs statistical analysis, makes statistical inference and writes and presents reports summarizing findings including publications in peer-reviewed journals.

• Collaborating with clinical investigators to determine study design;
• Writing sections of protocols that require statistical input;
• Reviewing protocols and case report forms to ensure that protocol objectives are met and standards are maintained;
• Generating treatment allocations in randomized clinical research studies and ensuring proper implementation;
• Leading the project team's development of statistical analysis plans and programs to perform analyses and display study data;
• Performing statistical analyses; writing and validating application programs;
• Implementing data and safety monitoring reports to ensure participants' safety;
• Developing metrics and generating quality control reports to optimize the performance of clinical sites and the coordinating center;
• Generating study reports to be distributed to internal and external monitoring committees and regulatory bodies;
• Participating in professional development activities both within and outside the company
• Other duties as assigned

• PhD in biostatistics, statistics, epidemiology or related field.
• Demonstrated proficiency with statistical methods and applications in clinical research.
• Strong programming skills in SAS and/or R.
• Ability to manage multiple tasks.
• Ability to work independently, as well as in a team environment.
• Ability to effectively communicate technical concepts, both written and oral.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, or other legally protected characteristics.

#LI-Remote

Associate Project Leader

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower-level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Associate Project Leader:

-Bachelor's degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO;

-Master's degree with at least 4 years of experience within pharma and/or CRO;

-PhD with at least 1 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles appropriate to the position with a typical tenure of at least 1 year management experience in a research environment.

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  Highly motivated with ability to work independently and as part of a multi-disciplinary team
  Strong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Clinical Operations Intern

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Clinical Operations intern supports clinical trial activities and works closely with the clinical operations team to ensure department activities are conducted according to required activity quality standard.

• General administrative support to the clinical operations department.
• Assist in managing trial timelines.
• Assess and provide feedback on approaches to maximize efficiencies and identify opportunities for improvement.
• General administrative support of clinical operations department storage platforms (e.g. Sharepoint, etc.)
• Assist in tracking of trial activities which may include but are not limited to feasibility, site selection, participation status, regulatory or ethics status.
• Participates in department and/ or clinical trial team meetings and participate in collaborative efforts.

• Undergraduate student; junior or senior preferred.
• Understanding of study phases and general knowledge of how they apply to clinical development is preferred.
• Knowledge of Word, Excel, SharePoint and PowerPoint.
• Strong verbal and written communication skills required.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Job Title: Project Delivery Manager (Ophthalmology) - OptymEdge

Location: Remote in US, Canada & UK

OptymEdge, (part of the Emmes Group), develops proven solutions for training and certification of Visual Function Examiners and Visual Acuity Rooms. OptymEdge partners with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data.

OptymEdge is the largest and longest-standing certification organization in the industry. We pioneered visual acuity certification from conception. Our services have grown to be synonymous with providing the highest level of quality and standardization of clinical trial data.

• Over 2,500 sites certified worldwide, since 1995

• Phase I through post-marketing experience across anterior segment and retina trials

• Clinical Ophthalmology, Optometry, and clinical trial expertise

Primary Purpose

The Project Delivery Manager (PDM) is critical to the successful conduct of ophthalmic certifications in Biopharmaceutical-sponsored clinical trials, as a matrix leader of a vendor project team. The OCPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The PDM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management.

* Serves as the primary point of contact for biopharma clients and demonstrates proficiency in knowledge and understanding of client needs.
* Ensures that deliverables for the assigned projects are completed according to the contract budget, schedule, and quality standards. Projects will be effectively managed in all areas of performance.
* Develops successful working relationships with clients, executive management, and project staff and collaborates to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
* Tracks project deliverables against contract. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and agrees to mitigation plans with the project team to be presented to the client.
* Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
* Identifies and manages changes to scope and requests for out-of-scope activities. Collaborates with Business Development, Contracts Department, and executive management to ensure timel y execution of contract amendments/change orders. Prospectively manages client expectations.
* Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
* Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
* Performs other duties as assigned.

* Bachelor's degree or equivalent experience.

* Experienced in developing and maintaining customer relationships.
* Minimum 2 years demonstrating related experience.

* Experience with MS Office Suite.
* Time management and decision-making skills.
* Attention to detail and the ability to address several assignments simultaneously.
* Excellent oral and written communication skills.
* Some knowledge of clinical trials in ophthalmology preferred.

* Occasional travel may be required on an ad hoc basis

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Biostatistician Manager

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Oversees statistical activities and deliverables across a project or platform of related clinical research studies, leads a team of Statisticians and SAS Programmers and ensures that statistical deliverables are completed in a timely manner and with high quality. Serves as a lead statistician on multiple clinical research studies, from the initial design stage all the way to final report writing and manuscript preparation.

• Manages a team of Statisticians and SAS Programmers and is ultimately responsible for statistical deliverables across multiple projects or platforms of related clinical research studies.
• Serves as a lead statistician on multiple clinical research studies, from initial study design through final report development and manuscript writing.
• Serves as a client point of contact for statistical deliverables, fostering a collaborative relationship with contract sponsors and Emmes project team members.
• Represents Emmes at Sponsor, Regulatory, Investigator or Safety Review meetings (e.g., Data and Safety Monitoring Board Meetings).
• Manages project statistical resources (i.e. budget and personnel) to ensure statistical tasks are completed on schedule and that each project has adequate staffing levels.
• Establishes budgets for statistical activities on new project work.
• Identifies statistical and operational issues and proposes solutions.
• Oversees the conduct of a clinical trial/project and quality control at the clinical center(s) and the data coordinating center and communicates issues to the appropriate oversight committees.
• Prepares, reviews and/or approves clinical project material that requires statistical input to ensure that the documents are scientifically valid and feasible.
• Supervises and mentors more junior statistical staff and provides opportunities for career growth.
• Participates in recruiting activities for new statistical staff members and provides input on hiring decisions.
• Reviews work processes, schedules and checklists to ensure that all routine activities, as documented in corporate and project-specific Standard Operating Procedures (SOPs), are efficiently performed.
• Participates in project and corporate quality assurance activities, particularly those of a statistical nature.
• Ensures that project staff is trained and mentored, supervises project staff and performs personnel reviews.
• Provides project updates to Senior Biostatistician Managers.
• Other duties as assigned

• MS or PhD in statistics, biostatistics, epidemiology or related field.
• At least 4 (with PhD) or 6 (with MS) years of related experience; including leading a clinical research team and supervising senior level statistical staff.
• Expertise in state-of-the-art data manipulation and statistical analyses.
• Proven effective leadership of a clinical research team.
• Strong skills in prioritization, problem-solving, organization, decision-making, time management, negotiation, mentoring and planning.
• Self-motivated, proactive and detail oriented.
• Demonstrated ability to manage multiple tasks, while working independently.
• Ability to effectively communicate technical concepts, both written and oral.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Clinical Program Manager - Essex Management

Remote in US except, if in Maryland, DC, VA & Delaware; must be comfortable in being on client site at least once a week.

This position supports "Essex, an Emmes Company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

We are seeking a highimpact, strategic, and executionoriented directorlevel Program Manager to lead and mature the organization's program strategy, delivery excellence, and client enablement capabilities. This role provides both strategic leadership and handson management, including direct oversight of staff and responsibility for career development, coaching, and performance management.

This role will shape how internal departmental initiatives and client programs are planned, governed, staffed, measured, and communicated, ensuring delivery rigor while enabling flexibility and innovation across diverse client environments.

This role works in close partnership with portfolio, engineering, bioinformatics, data science, and business development leadership to ensure integrated delivery, effective resource utilization, proactive risk management, and an exceptional client experience.

The ideal candidate is a decisive people leader and systems thinker who thrives in complex and evolving environments, balances strategy with execution, and brings a strong client first mindset. Success requires the ability to influence at the executive level, mature organizational capabilities, and cultivate a collaborative, empowered team culture that supports excellence in deliveryfirst mindset. Success requires the ability to influence at the executive level, mature organizational capabilities, and cultivate a collaborative, empowered team culture that supports excellence in delivery.

• Establish and execute departmental goals and objectives aligned to enterprise strategy, contract priorities, and client mission outcomes; define and monitor KPIs to drive accountability and data-informed decision-making.
• Design, implement, and continuously mature program management, governance, and delivery enablement frameworks that scale across portfolios while ensuring compliance with federal, regulatory, and organizational standards.
• Provide executive-level visibility into portfolio, program, and project health through standardized dashboards, metrics, and reporting-enabling proactive management of risks, issues, dependencies, and performance trends.
• Partner with portfolio and divisional leadership to support investment prioritization, funding decisions, and resource allocation, balancing client commitments, growth objectives, and staff sustainability.
• Ensure full lifecycle contract execution excellence, including initiation, execution, closeout, client reporting, lessons learned, and continuous improvement integration.
• Lead people management strategy for the department, including performance management, career development, succession planning, training pathways, and promotion readiness.
• Own departmental workforce and strategic resource planning, including forecasting, recruitment, onboarding, capacity planning, skills development, and certification alignment.
• Ensure compliance with staff allocations plans, time reporting, and internal policies across billable, internal, and strategic initiatives.
• Actively support business development efforts, including RFP solutioning, staffing models, transition planning, delivery onboarding, and ongoing executive client engagement.
• Champion quality-by-design principles across all delivery artifacts and processes; oversee SOP evolution, process training, internal audits, and continuous improvement initiatives.
• Maintain strong awareness of industry, regulatory, and technology trends; represent the organization through thought leadership, publications, conferences, and strategic forums.

Required Skills:

• Advanced expertise in program, portfolio, and PMO leadership, including framework design, governance models, and delivery maturity assessments (e.g., PMI, PMO, Agile/Hybrid environments).
• Strong command of program operations, including financial management, forecasting, risk and issue management, resource optimization, and executive reporting.
• Demonstrated experience leading complex life sciences and health IT programs supporting clinical research, bioinformatics, public health, biomedical informatics, and regulated data environments.
• Exceptional communication and executive presence, with the ability to influence senior leaders, advise clients, and align cross-functional teams around shared outcomes.
• Proven problem-solving and systems-thinking capabilities, with a track record of driving process improvement, operational scalability, and organizational maturity.
• Ability to rapidly assess priorities, adapt to evolving client environments, and translate strategy into executable roadmaps.
• Strong regulatory and compliance knowledge, including clinical research regulations, healthcare privacy, and federal IT compliance standards (e.g., FDA, 21 CFR Part 11, HIPAA, FISMA, FedRAMP, CMMI, ISO).
• Experience operating in federal health environments (e.g., HHS, NIH, NCI), with familiarity across consulting delivery models, contract vehicles, and business development lifecycle.

Required Areas of Focus:

Program Management Leadership

• Own and evolve client-facing program and project roadmaps, ensuring alignment with mission goals, regulatory requirements, funding constraints, and delivery capacity
• Contribute to standardized BD-to-Delivery transition processes, ensuring early engagement, clarity of scope, staffing, budgets, timelines, and accountability prior to execution.
• Ensure consistent contract execution through disciplined tracking of deliverables, milestones, financials, and performance metrics, including CPAR inputs and self-assessments.
• Design, maintain, and continuously improve enterprise delivery dashboards, providing visibility into:

• • Program and project health summary
  • Resource utilization and capacity
  • Budget performance and forecasting
  • Risk and issue trends
  • Key milestones and outcomes

Contract performance and quality metrics

• Establish and enforce a structured reporting cadence to support proactive leadership engagement and timely decision-making:

• • Weekly: Project and program status
  • Monthly: Portfolio performance and financial reviews
  • Quarterly: Strategic outlook, risk posture, and growth alignment

• Serve as a senior client relationship leader, cultivating trusted partnerships and proactively identifying opportunities to enhance delivery value and expand engagements.

Financial & Resource Management

• Partner with leadership teams to define, manage, and optimize portfolio, program, and project-level budgets.
• Develop and maintain a comprehensive resource capability matrix capturing skills, certifications, experience, performance insights, and availability.
• Optimize workforce utilization by aligning staffing decisions with delivery needs, staff development goals, and long-term organizational strategy.
• Lead and support staff transitions, onboarding, promotions, and role changes with minimal delivery disruption.
• Drive training and capability development strategies aligned to SOPs, industry standards, and evolving client needs.

Stakeholder Engagement & Communication

• Act as a senior liaison between executive leadership, program teams, and client stakeholders.
• Strengthen client partnerships through structured feedback mechanisms, contract / project performance reviews, and strategic planning engagements to support change agility and account growth.
• Enable cross-division collaboration to ensure integrated delivery and shared accountability.
• Communicate performance, risks, and opportunities through clear dashboards, briefings, and executive presentations.

Advisory & Consultation

• Provide strategic advisory services to internal and external stakeholders navigating complex program and project and delivery challenges.
• Translate technical, business domain, and operational concepts into actionable strategies that enable informed decision-making.
• Serve as a trusted advisor supporting both delivery excellence and organizational growth.

• Education: Bachelor's degree required; Master's degree in a scientific, health, or program management discipline preferred. PMP or equivalent certification desired.
• Experience: Minimum of 10 years in senior program strategy and delivery leadership roles across federal, academic, and private-sector environments.
• Program Leadership: Extensive experience program management, PMO leadership, governance, financial management, and large-scale delivery enablement.
• Industry Knowledge: Strong background in life sciences, clinical research, bioinformatics, health informatics, and public health.
• Leadership & Business Acumen: Proven ability to lead distributed teams, manage complex stakeholder environments, and influence at the executive level.
• Business Development: Demonstrated success supporting client growth, solution design, and consulting delivery models.
• Federal Health IT Experience: Experience supporting HHS, NIH, NCI, or similar agencies strongly preferred.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Project Leader: Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  Highly motivated with ability to work independently and as part of a multi-disciplinary team
  Strong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Safety Monitor II

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements.

• Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members.
• Reviews safety events.
• Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
• Provides first line evaluation of serious adverse events (SAEs).
• Communicates with site staff regarding reported AEs or SAEs to gather additional information.
• Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• Coordinates the timely completion and submission of required reports to health authorities and business partners.
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
• Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
• Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non interventional).
• Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary.
• Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports.
• Coordinates with project staff.
• Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
• Contributes to the development and implementation of safety related Case Report Forms (CRF) and SaMP.
• Ensures maintenance of documentation required by both corporate and project SOPs.
• Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Guarantees compliance and adherence to the quality standards.
• Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned.
• Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract.
• Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
• Completes all relevant professional training in the given scope and time frame.
• Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives.

• Bachelor's Degree in Pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice, example pharmacy, inpatient or outpatient healthcare facility, or clinical research center.
• 1-3 years in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) required
• Experience in safety monitoring/pharmacovigilance preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Job Title: Recruiter (Government Sector)

Location: US Remote (Must be able to work East Coast hours.)

Employment Type: This is a temporary role on a PT basis.

Hours of Employment: Ideally we're seeking someone who can support US business hours but please note that due to the nature of the work, there may be times where you'll have to have some meetings after business hours.

This position supports "Essex, an Emmes Company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

Primary Purpose

Essex Management is seeking an experiencedRecruiter on a contract basis to support our growing hiring needs across government programs. This role is responsible for full life-cycle recruiting, from sourcing and engaging talent to managing the interview process, extending offers, and supporting onboarding activities. The ideal candidate has prior experience recruiting for government contracting organizations, understands the unique requirements of federal hiring (clearances, compliance, etc.), and thrives in a fast-paced environment.

This is a contract role and requires availability to work East Coast (ET) hours.

• Manage full life-cycle recruiting across multiple open roles supporting government programs.

• Assist in developing Job Description and creating job requisitions in the Applicant Tracking System (ATS).

• Source and attract candidates using job boards, LinkedIn, referrals, and other recruiting channels.

• Conduct initial candidate outreach and screening to assess qualifications, experience, and cultural fit.

• Shepherd candidates through the interview process, coordinating with hiring managers and ensuring a positive candidate experience.

• Facilitate feedback collection and maintain consistent communication with candidates and internal stakeholders.

• Prepare and extend offers, negotiate compensation when appropriate, and work to successfully close candidates.

• Coordinate and manage the background check process, ensuring compliance with company and government requirements.

• Support portions of the onboarding process, including candidate documentation, communication with HR, and start-date coordination.

• Maintain accurate records within the Applicant Tracking System (ATS) and ensure recruiting activity is properly documented.

• Partner closely with hiring managers to understand role requirements and build effective recruiting strategies.

• Ensure recruiting practices align with federal contracting compliance requirements and company policies.

• 3+ years of recruiting experience, with at least 1-2 years supporting government contracting organizations.

• Demonstrated experience managing full life-cycle recruiting

• Experience recruiting for roles supporting federal programs or government clients.

• Strong sourcing capabilities using platforms such as LinkedIn Recruiter, job boards, and professional networks.

• Ability to manage multiple requisitions simultaneously in a fast-paced environment.

• Excellent communication, organizational, and stakeholder management skills.

• Experience coordinating background checks and supporting onboarding processes.

• Experience working with ATS platforms (we use iCIMS) and background check systems (we use SkillSurvey & HireRight).

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Global Project Manager - Ophthalmology

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Global Project Manager (GPM) is critical to the successful conduct of Biopharmaceutical -sponsored clinical trials as a matrix leader of the core project team. The GPM is responsible for the successful delivery of a Biopharmaceutical project(s). The GPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The GPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through relationship management.

• May serve as a primary lead for project bids and multi trial initiatives.
• Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Effectively manages projects in all areas of performance.
• Develops effective working relationships with clients, executive management, and project staff. Collaborates with stakeholders to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
• Serves as the primary point of contact for biopharma clients. Demonstrates proficiency in knowledge and understanding of client needs.
• Tracks project deliverables against contract using Emmes' tools. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and collaborates with the project team to develop mitigation plans to be presented to the client.
• Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
• Manages project resources (i.e., budget, personnel, and subcontracts).
• Identifies and manages change to scope and requests for out-of-scope activities. Collaborates with Business Development, the Contracts Team, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations.
• May present in bid defense meetings in collaboration with Business Development.
• Develops study management plans in collaboration with core project team members.
• Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
• Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
• Performs other duties as assigned.

• Bachelor's degree in a scientific discipline.
• Minimum 8 years demonstrating scientific principles appropriate in managing a clinical research portfolio including multi-phase research experience in a broad range of indications and client types.
• At least 3 years working in a pharmaceutical and/or CRO setting, serving in a global Trial Team Lead or Global Project Management role or equivalent position.
• Minimum of 2 years of experience in Ophthalmology clinical trials, 5 years of experience preferred.
• Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-4, in a global capacity.
• Demonstrated experience in developing and fostering client and internal relationships.
• Thorough understanding of ICH GCP and applicable global regulatory regulations and
  guidelines.
• Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions.
• Successful record in managing diverse staff and leading strong teams.
• Strong verbal and written communication skills.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Staff UI/UX Designer - Essex Management

US Remote

Please remember to include a link to your online portfolio on your resume and if the site is password protected, how to access it so we can review.

This position supports "Essex, an Emmes Company". Essex is a biomedical informatics and health information technology-focused consultancy founded in 2009 and headquartered in Rockville, MD. The Essex team comprises experts with extensive experience in strategically developing and managing complex health and biomedical information programs for clients in the Federal Government, research academia, and private sectors.

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

This role works as part of the Essex Modern Technology & Engineering (MT&E) team and will be focused on owning and driving the Human Centered Design (HCD) capability at the company. This is a senior Staff-level role with operational and strategic deliverables across client-facing projects and internal company initiatives. The role will be responsible for developing user interfaces, design system(s), and providing design strategy/leadership to support life science research in the public and/or private industry. This role will work on client project deliverables as well as in-house Essex deliverables to grow the overall Essex Human-Centered Design (HCD) capability. The role provides strong career growth opportunities in an innovative technology environment working with premier research organizations.

1. Own and drive the Human Centered Design (HCD) capability at
2. Lead the development of design solutions that solve complex and challenging UI/UX problems.
3. Meet with engineering team leads, and business and product owners to kick-off the design process at project inception.
4. Design clean, accessible, and modern UIs that adhere to the unified principles of a
   design system.
5. Develop documentation, including design process working practices, design system guides, and knowledge presentations.
6. Provide UI/UX design leadership and advocacy across multiple concurrent projects-both customer-facing and internal. Establish and guide the overall design vision, user-experience strategy, and brand direction for each initiative.
7. Work in a collaborative cross-functional team environment to deliver UI mocks and wireframes tied to features across all tiers in a CI/CD Agile environment.
8. Leverage any combination of UX research techniques (e.g., card sorting, story maps) to achieve the desired design deliverable goals.
9. Collaborate with cross-functional teams, when necessary, to complete cross-project initiatives (e.g., accessibility compliance, design system updates).
10. Mentor members of the design team to provide career path guidance.
11. Interview UI/UX design candidate(s) and provide evaluation/recommendation to the
    hiring manager.
12. Take ownership of the design interview and evaluation process. Define and improve the process based on industry conventions and evolving trends.
13. Own and drive in-house design projects that are used to improve the company's Human Centered Design (HCD) capabilities.
14. Contribute to the company's business development activity (e.g., providing design and branding content, and reviewing proposal responses.
15. Conduct Voluntary Product Accessibility Template (VPAT) reviews across multiple projects and BD initiatives.
16. Work effectively with teams outside of engineering across the Essex organization on key company and/or UI/UX branding initiatives.

1. A deep understanding of design techniques and principles involved in the production of conceptual prototypes and wireframes.
2. Subject matter expertise in accessibility, accessibility tools, VPAT reviews, application interaction design, and design systems and frameworks (Bootstrap, Foundation, USWDS).
3. Experience providing design and accessibility deliverables on multiple projects
   running concurrently.
4. Comprehensive experience using Adobe Creative Suite (Photoshop, Illustrator, XD)
5. Excellent understanding of and experience with design collaboration tools such as Figma.
6. Excellent communication (oral and written) and collaboration skills.
7. Strong analytical skills with the ability to communicate concepts and recommendations confidently to a variety of audiences.
8. Thorough, methodical, and exhibits meticulous attention to detail.
9. Working knowledge of the following technologies and software: LucidChart, HTML, and
   CSS (SCSS).
10. 10+ years of UI/UX design experience.
11. Possession of a Bachelor or Graduate degree in Design or Human-Computer Interaction.
12. A portfolio of professional UI/UX web design work.

Though not mandatory but bonus points for:

1. Possession of at least one of the following UI/UX certifications: UXC (Nielsen Norman Group UX Certification OR CUA (Human Factors International Certified Usability Analyst)
2. Experience working with USWDS (United States Web Design System).

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Singlewire Software, based in Madison, Wisconsin, is dedicated to shaping a future where every organization can protect its people with confidence. We deliver innovative solutions, including InformaCast critical communication and incident management software, the InformaCast Wearable Alert Badge, and Visitor Aware visitor and safety management software.

Our technology helps organizations instantly reach the right people, coordinate responses, and manage critical events - empowering schools, healthcare systems, manufacturers, enterprises, and public organizations to create safer environments.

Just as important as what we build is how we work. We're a collaborative, supportive team that cares deeply about our mission, our customers, and each other.

This is not a "get coffee and observe" internship.

As a Marketing Intern at Singlewire, you'll gain hands-on experience across multiple areas of modern B2B marketing while working alongside experienced professionals in strategy, content, design, video, events, and campaigns.

You'll support real projects that impact the business while building practical skills you can take into your career.

If you're curious about marketing and want exposure to many different specialties, this role is designed for you.

You'll work closely with the Director of Communications while supporting initiatives across the entire marketing team, including leadership, campaign strategy, creative production, and partner marketing.

Your responsibilities may include:

• 
  
• Participate in brainstorming and development of marketing campaigns
  
• Assist with campaign execution across multiple channels
  
• Support brand initiatives, including updating materials to reflect new messaging
  

• 
  
• Draft written content, such as:
  
  
  • 
    
  • Blog articles
    
  • Social media posts
    
  • Sales and marketing collateral
    
  • Email copy
    
  • Video scripts
    
  • Presentations and ebooks
    
  
  
  
• Conduct research to support content development and messaging
  

• 
  
• Assist with graphic design projects using tools like Canva or Adobe
  
• Support video production, including filming and editing short-form content
  
• Help organize creative assets and marketing materials
  

• 
  
• Research competitors and industry trends
  
• Use AI tools to analyze customer conversations and internal data to uncover insights that support sales and marketing strategy
  

• 
  
• Collaborate with multiple marketing roles and internal departments including:
  
  
  • 
    
  • Marketing leadership
    
  • Campaign management
    
  • Design
    
  • Video production
    
  • Partner and event marketing
    
  • Sales
    
  • Product development
    
  
  
  
• Assist with the organization, coordination, and execution of marketing projects
  

No travel is expected for this role.

• 
  
• Exposure to multiple marketing disciplines - not just one area
  
• Direct mentorship from experienced marketing leaders
  
• Opportunity to build a portfolio of real work
  
• Experience with modern marketing tools, including AI
  
• A chance to contribute to a mission-driven company focused on safety and impact
  

Required:

• 
  
• Currently enrolled in a college or university program (Marketing, Communications, or related field preferred)
  
• Strong written and verbal communication skills
  
• Excellent attention to detail and organization
  
• Ability to manage multiple projects and deadlines
  
• Curiosity and willingness to learn
  
• Experience using AI tools such as ChatGPT or Gemini
  
• Experience with Microsoft Office or Google Workspace
  

Nice to Have (but not required):

• 
  
• Prior experience in a marketing role for a B2B company
  
• Graphic design experience
  
• Familiarity with Adobe Creative Suite, Canva, or similar tools
  
• Video editing experience
  

Most importantly, we're looking for someone who is motivated, reliable, and excited to grow.

At Singlewire, we believe what we do truly matters. We're passionate about protecting people and helping organizations respond when it counts. We're a team of collaborators who support each other, work hard toward shared goals, and celebrate successes together.

Singlewire Software LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, age, veteran status, disability status, or other protected characteristics.

Biostatistician Intern

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Biostatistics Intern is responsible for working closely with biostatisticians on biomedical research projects across a variety of therapeutic areas. Interns meet with epidemiologists, project coordinators, and biomedical investigators and will contribute to the design, analysis and reporting of clinical research projects.

• Contribute to the review of sample size and other statistical aspects of study design
• Perform statistical analysis and prepare summary reports and visualizations
• Perform quality control (QC) for statistical deliverables prepared by other staff
• Participate in presentations to biomedical investigators or manuscript preparation
• Assist with review and finalization of research data sets for statistical analysis

• Currently enrolled Masters/PhD student in statistics or biostatistics
• Excellent analytical/problem solving skills
• Strong attention to detail
• Ability to manage priorities effectively
• Familiarity with SAS or R programming

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Associate Biostatistician

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Collaborates with clinical investigators to determine study design, contributes to protocol development, writes statistical analysis plans, makes statistical inference, and writes and presents reports summarizing findings including publications in peer-reviewed journals.

• Contributes to manuscripts and/or scientific presentations.
• Collaborates with clinical investigators to determine study design.
• Writes sections of protocols that require statistical input.
• Reviews protocols and case report forms to ensure protocol objectives are met and standards are maintained.
• Generates treatment allocations in randomized clinical research studies and ensures proper implementation.
• Supports development of statistical analysis plans and programs to perform analyses and display study data.
• Performs statistical analyses and writes and validates application programs.
• Implements data and safety monitoring reports to ensure participants' safety.
• Generates quality control and operational reports to support clinical operations.
• Generates study reports to be distributed to internal and external monitoring committees and regulatory bodies including, but not limited to, Data and Safety Monitoring Board reports, IND annual reports, and Clinical Study reports.
• Participates in professional development activities both within and outside the company.
• Other duties as assigned.

• MS in biostatistics, statistics, epidemiology or related field.
• Demonstrated proficiency with statistical methods and applications in clinical research.
• Strong programming skills in SAS and/or R.
• Expertise in state-of-the-art data manipulation and statistical methodology.
• Ability to manage multiple tasks.
• Ability to work independently as well as in a team environment.
• Ability to effectively communicate complex statistical concepts, both written and oral.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Singlewire Software, based in Madison, Wisconsin, is dedicated to shaping a future where every organization can protect its people with confidence. We deliver innovative solutions, including InformaCast critical communication and incident management software, the InformaCast Wearable Alert Badge, and Visitor Aware visitor and safety management software.

Our technology helps organizations instantly reach the right people, coordinate responses, and manage critical events - empowering schools, healthcare systems, manufacturers, enterprises, and public organizations to create safer environments.

Just as important as what we build is how we work. We're a collaborative, supportive team that cares deeply about our mission, our customers, and each other.

An exciting opportunity is available for a Software Order Fulfillment and Customer Service Specialist to join the Singlewire team. This position will be part of Singlewire's sales operations team. If you are passionate about working with others and enjoy working in a fast-paced environment - this might be the position for you!

What You'll Do

The Order Fulfillment & Customer Service Specialist is responsible for processing and fulfilling all sales orders while providing the highest level of customer service and sales support to our customers and partners. Our ideal candidate will exhibit people skills and extreme attention to detail, is a team player and a problem solver with critical thinking skills.

Your responsibilities may include:

• 
  
• Responsible for processing orders. With attention to detail, a sense of urgency, and critical thinking to fulfill the complex orders we receive into our system.
  
• Work with Sales or others to obtain necessary documentation required for each order.
  
• Review contracts, verify data and order paperwork for completeness and accuracy.
  
• Communicate with our customers and partners and assist in the support requests related to licensing upgrades, reallocations, and provisioning.
  
• Maintain/Update customer information and files as needed. (Addresses, Tax Documents, etc.)
  
• This individual will be trained on multiple responsibilities. As our business needs change, they will be flexible, shifting their time between job responsibilities/functions.
  

No travel is expected for this role.

Required Qualifications:

• 
  
• Associate degree or other equivalent experience in areas relating to order fulfillment, customer service or data entry required
  
• 2+ years of customer service experience
  
• Experience with computer programs including MS Office
  

Preferred Qualifications:

• 
  
• Experience with Salesforce or other CRMs
  
• Extreme attention to detail. Excellent research and problem-solving skills.
  
• Excellent verbal and written communication skills.
  
• Disciplined, self-motivated, organized, and reliable.
  
• Possesses a positive attitude with excellent interpersonal skills and the ability to interact and build strong working relationships with customers as well as peers at all levels.
  
• Ability to prioritize tasks, think on your feet and be able to work around uses that may arise, to effectively optimize productivity.
  
• Ability to work in a team environment and adapt to changing workload and circumstances effectively; able to respond to new information quickly.
  
• Excellent math ability, with good analytical skills.
  
• Stellar work ethic and attitude.
  

At Singlewire, we believe what we do truly matters. We're passionate about protecting people and helping organizations respond when it counts. We're a team of collaborators who support each other, work hard toward shared goals, and celebrate successes together.

Singlewire Software LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, gender identity, sexual orientation, age, veteran status, disability status, or other protected characteristics.

Labor & Employment Associate

Our client, a top AmLaw 50 firm, is seeking a mid-level Labor & Employment Associate to join its Chicago office. The ideal candidate will handle significant responsibilities in employment law litigation matters through summary judgment and trial, including discovery (e-discovery), motions practice in federal and state courts, and responding to administrative agency charges and investigations. The role also involves employment law counseling, advising in-house counsel, HR professionals, and company representatives on employment relationship issues.

The estimated salary range for this position is $230,000 – $340,000 (annually) and may vary depending on experience and other factors.

Qualifications

• Must be authorized to work in the U.S.
• Must be admitted to and in good standing with the Illinois Bar
• 4+ years of general labor and employment law and litigation experience at a large law firm
• Experience with employment litigation through summary judgment and trial, with minimal supervision
• Experience with wage and hour matters, restrictive covenant, and trade secret matters
• Employment law counseling experience, including drafting employment contracts
• Superior writing skills and strong academic credentials required

About Us

Marina Sirras & Associates LLC is a boutique legal recruiting firm committed to connecting exceptional legal talent with top-tier law firms and in-house legal departments nationwide. With decades of experience and a personalized, relationship-driven approach, we take pride in understanding the unique needs of both our clients and candidates.

We are a proud member of the National Association of Legal Search Consultants (NALSC) and strictly adhere to the NALSC Code of Ethics. Marina Sirras, our founder, is a former President and Chairperson of the organization, reflecting our longstanding commitment to integrity and professionalism in legal recruiting.

To learn more about our team and services, please visit us at