Jobs in Washington Grove, MD

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

Proposal 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

An experienced role, responsible for leading the assigned proposal team in the development of high quality, compliant and timely proposals for the U.S. government and other organizations conducting biomedical research including clinical trial. The Proposal Manager uses Emmes' proposal process, tools, and corporate policies to plan, manage, and contribute to all stages of the development of proposals with a high degree of professionalism and collaboration. Works alongside the Proposal Department leadership and other team members to refine processes and tools, evolve our services, and win opportunities to conduct research or the IT systems that support research that improves public health and impacts lives.

• Manage proposal response teams of varying sizes, comprised of BD, solution leads, SMES, and members of the pricing team, to complete a structured response addressing all client requirements, meets capture strategy, and is submitted on time
• Work with the Government BD and Capture teams to support Emmes' capture efforts, understand the messaging strategy established in the capture phase and establish a proposal plan that adheres to the win strategy and messaging established by the team; review draft and provide feedback on how the goals, issues, features, benefits, and proofs have cascaded through the response
• Shred solicitation requirements to develop response plans that follow Emmes' proposal development and review process for government and non-government solicitations.
• Work with the proposal teams and appropriate leadership to identify, mitigate, and resolve issues, questions, and challenges surrounding the proposal
• Organize, write, edit, and format proposals consistent with client response instructions using Emmes templates, providing first draft responses using the content library and creating content as needed
• Provide ongoing proposal content support including editing of SME-provided content, consistent formatting, logical copy flow and single tone of voice
• When partners, vendors, or subcontractors are included in the strategy, ensure these third parties understand content needs and associated deadlines, and resolve associated issues as needed to move the proposal process forward
• risks to the proposal process, and collaborate with department team members on continual improvement
• Contribute to the content management of the proposal re-use library text, graphics, and templates, including the use of tools, e.g., GovDash or Responsive
• Manage Emmes proposal data for facilitation, tracking, and evaluation of proposal progress
• Provide thought leadership and manage projects that elevate the department's processes, tools, and skills
• Able to wear multiple hats in the proposal and content development roles and be flexible with the needs of individual proposal response team members to reach the end goal of a compliant, best-quality, submitted proposal within the allotted time
• Other duties as assigned

• Bachelor's degree in English, Journalism, Business Administration, or a related discipline required or equivalent experience
• Minimum 3 years experience working in a professional, post-collegiate environment with a degree or 6 -7 years without a degree
• Minimum 3 years experience full-time proposal experience, in which managing proposals is the primary job function
• Experience with CRO or IT proposals, preferred
• Experience with government solicitations, including IDIQ, GWAC, BPA, OTA, RFA/grant, and TO proposals, preferred
• Possesses user-level experience with Customer Relationship Management (CRM) systems and Content Management Systems, e.g., Dynamics 365 and GovDash preferred
• Demonstrates intermediate to advanced skills in Microsoft Office Suite products and Adobe Acrobat, including working knowledge of Visio and PowerPoint
• Maintains a professional and positive approach with proposal teams
• Demonstrates the following skills at a level of excellence consistent with Emmes' Proposal Manager:
  • Takes ownership of proposals from assignment to submission, including persistence in problem solving
  • Writing and communication skills
  • Organizational skills
  • Initiative and ability to exercise sound independent judgment
  • Business acumen, serving internal and external clients, and balancing assertiveness with flexibility for the good of the proposal and the team
  • Ability to juggle conflicting priorities during the proposal process and makes decisions concerning the proposal
  • Ability to proactively identify risks to proposal, identify solutions, and collaborate with proposal team and/or proposal department leadership to mitigate as appropriate
  • Critical thinking skills and ability to play devil's advocate for the good of the proposal
  • Process management skills to find the most efficient critical path necessary to achieve the quality goals for the proposal
  • Time management skills to develop and manage an effective and realistic proposal timeline
  • Team- and relationship-building skills with assigned proposal teams

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

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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

Border Patrol Agent (BPA) Entry Level

NEW RECRUITMENT AND RETENTION INCENTIVES!

IMPORTANT NOTICE: Duty assignments available at the time of offer may include the Southwest Border, including prioritized locations.

U.S. Border Patrol determines duty assignments at the time of offer based on operational needs, which may or may not align with candidates' first-choice preferences. Relocation may be required.

DON'T FORGET TO CHECK OUT THE INCENTIVES – SEE SALARY SECTION BELOW

The U.S. Border Patrol (USBP) offers those interested in a career in law enforcement an opportunity to work with an elite team of highly trained professionals whose camaraderie, pride, and purpose are hallmarks of their daily mission of protecting America.

If you seek an exciting and rewarding job that provides excellent pay, exceptional federal benefits, and job stability, now is the time to make your move. U.S. Border Patrol (USBP), within the U.S. Customs and Border Protection (CBP), is hiring immediately for these full-time, entry-level, career Law Enforcement Officer (LEO) opportunities.

Salary and Benefits

Annual Base Salary for newly appointed BPAs varies per grade, as follows:

GL-5/GL-7 $49,739 - $89,518 per year

Duty location impacts pay rates; locality pay for federal law enforcement is higher in some locations than others. A fully trained BPA may be eligible for up to an additional 25% of base pay per the BPA Pay Reform Act of 2014. This is a career ladder position with a grade level progression of GL-5, GL-7, GL-9, GS-11, and GS-12. You will be eligible for a promotion to the next higher grade level (without reapplying) once you successfully complete 52 weeks in each grade level.

Border Patrol Agents are eligible to select from an array of federal employment benefits that include health, dental and other insurance plans, a generous annual and sick leave program, and participation in the Thrift Savings Plan, a retirement plan akin to a traditional ROTH 401(k) offering.

*Recruitment Incentive* Newly appointed Border Patrol Agents (as defined in 5 CFR 575.102 ) will be offered up to a $20,000 incentive. The first $10,000 will be paid upon successful completion of the Border Patrol Academy, with the remaining $10,000 awarded for accepting a prioritized location. Prioritized locations include Sierra Blanca, TX; Presidio, TX; Sanderson, TX; Comstock, TX; Lordsburg, NM; Freer, TX; Hebbronville, TX; Ajo, AZ.

*Retention Incentive* Newly appointed Border Patrol Agents may also qualify for up to $40,000 in additional incentives distributed over their first four years.

Duties and Responsibilities

As a BPA, you will be part of our 60,000+ workforce that strives to protect the American people by safeguarding our borders, deterring illicit activity, and enhancing the nation's economic prosperity. Being a BPA makes you a valuable member of the Federal Law Enforcement Officer (LEO) profession.

Typical assignments include:

• Detecting and questioning people suspected of violating immigration and custom laws and inspecting documents and possessions to determine citizenship or violations
• Preventing and apprehending undocumented noncitizens and smugglers of noncitizens at or near the borders by maintaining surveillance from covert positions to include using infrared scopes during night operations
• Interpreting and following tracks, marks, and other physical evidence of illegal entry of persons or contraband
• Performing farm checks, building checks, traffic checks, city patrols, and transportation checks
• Patrolling the international boundary and coastal waterways using a variety of government assets such as vehicles, horses, vessels, watercraft, off-road vehicles, ATVs, snowmobiles, and motorcycles for the accomplishment of the USBP Mission.

Qualifications

You qualify for the GL-5 grade level if you possess one of the following:

Experience: One (1) year of general work experience that demonstrates the ability to take charge, make sound decisions, and maintain composure in stressful situations; to learn regulations, methods, and techniques through classroom training and/or on-the-job instruction; and the ability to gather concise information through questioning, observation, and examination of documents and records; OR

Education Substitution: A bachelor's degree or successful completion of a full four-year course of study in any field leading to a bachelor's degree from an accredited college or university; OR

Combination of Experience and Education: A combination of general work experience AND successfully completed college education. This will be calculated using your resume and official or unofficial transcripts submitted with your application.

You qualify for the GL-7 grade level if you possess one of the following:

Experience: One year of specialized work experience that shows you have the skills necessary to:

• Make sound judgments and decisions in the use of firearms.
• Deal effectively with people in a courteous and tactful manner in connection with law enforcement matters.
• Analyze information rapidly and make prompt decisions where you will be expected to make arrests after the completion of required training and apply these skills in a law enforcement capacity such as criminal code enforcement, determining violations of laws, correctional or rehabilitation work involving criminal offenders, security, military, etc.

The above experience will be applied in connection with the following: Make arrests and exercise sound judgment in the use of firearms; deal effectively with people in a courteous manner in connection with law enforcement matters; analyze information rapidly and make prompt decisions; or develop and maintain contact with a network of informants.

Education Substitution for the GL-7 grade level: A bachelor's degree with superior academic achievement, which is based on (1) class standing, (2) grade-point average (i.e., GPA of 3.0 or higher out of a possible 4.0), or (3) honor society membership. Or will receive a bachelor's degree with Superior Academic Achievement. Or one full year of graduate-level education in a field of study related to law enforcement (e.g., criminal justice, homeland security, justice studies, law enforcement, courts and judicial systems, forensic technology, forensic psychology, or corrections and rehabilitation) from an accredited college or university; OR

A Combination of Experience and Education: This will be calculated using your resume and official or unofficial transcripts submitted with your application.

Note: If you have previous or current law enforcement or military law enforcement experience, you may qualify at the GL-9 and or GS-11 grade level. Please refer to the BPA GL-9 - 11 announcement.

Other Requirements

Citizenship: You must be a U.S. Citizen to apply for this position.

Residency: You must have had primary U.S. residency (includes protectorates as declared under international law) for at least three of the last five years.

Age Restriction: In accordance with Public Law 100-238, this position is covered under law enforcement retirement provisions. Candidates must be referred for selection to the Border Patrol Agent position before reaching their 40th birthday in accordance with Department of Homeland Security Directive 251-03. The age restriction may not apply if you are currently serving or have previously served in a federal civilian law enforcement (non-military) position covered by Title 5 U.S.C. 8336(c) or Title 5 U.S.C. 8412(d).

Veterans' Preference: You may also be eligible for an excepted service Veterans Recruitment Appointment (VRA). The age restriction does not apply if you are Veterans' Preference eligible.

Formal Training: After you are hired, you will be detailed to the U.S. Border Patrol Academy in Artesia, New Mexico, for approximately six (6) months of intensive instruction in immigration and nationality laws, law enforcement and USBP-specific operations, driver training, physical techniques, firearms, and other courses. Border Patrol work requires the ability to speak and read Spanish, as well as English. Border Patrol Agents will be provided training to become proficient with the Spanish language at the Academy.

How to Apply:

Click the Apply button on this site. You will be linked to the CBP Talent Network registration page. For Position of Interest, select Border Patrol Agent, then complete the pre-screening questions.

You'll then receive a link(s) to the BPA Job Opening Announcements (JOAs) on USAJOBS, the federal government's official employment site, to complete your application. Be certain to review ALL details of the job opportunity announcement and follow all instructions in the application process, including items (resume, transcripts, etc.) to submit. You will be evaluated based on your resume, supporting documents, and the BPA Entrance Exam.

If you have questions about the application process, contact a recruiter through the U.S. Border Patrol page: /s/usbp.

As a subscriber to the CBP Talent Network, you'll receive monthly emails with information about webinars, career expos, and future opportunities with CBP.

FULL-SERVICE SHOPPER

Start earning quickly with a flexible schedule

Shopping with Instacart is more than grocery delivery. Shoppers help make our world go round. They make money, make moves, and make shopping lists come true. They make good time, make life easier, and make people's day.

Shoppers make it all happen—sign up now to help create a world where everyone has access to the food they love.

As a full-service shopper, you'll receive orders through the Shopper app to shop from stores in your area, and deliver the orders to your customer's door. It's that simple.

What you get as a shopper:

• Start earning quickly on a flexible schedule*
• Weekly pay with the option of instant cashout
• Potential to earn tips
• Special earnings promotions

Basic requirements:

• 18+ years old (21+ to deliver alcohol)
• Eligible to work in the United States
• Consistent access to a vehicle and a recent smartphone

Additional information:

Shopping with Instacart is great for anyone looking for flexible, seasonal, home-based, entry-level, weekend, weekday, after-school, or temporary opportunities. As an Instacart Full-Service Shopper, you can have more flexibility than with a part-time job.

Instacart is committed to diversity and providing equal opportunities for independent contractors. Instacart considers qualified individuals without regard to gender, sexual orientation, race, veteran, disability status, or other categories protected by applicable law.

Instacart also values providing prospective contractors with a fair chance to pursue opportunities. For all individuals seeking to provide services in San Francisco, Los Angeles, and Philadelphia, Instacart considers individuals in a manner consistent with the requirements of applicable Fair Chance ordinances.

Review the Independent Contractor Agreement here

*Subject to availability of batches in your area.