Engineering Journal Impact Factor Jobs in Olney, MD

Overview

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.

Responsibilities

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

Qualifications

* 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

Overview

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.

Responsibilities

• 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.

Qualifications

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

Overview

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.

Responsibilities

• 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.

Qualifications

• 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

Overview

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.

Responsibilities

* 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.

Qualifications

* 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

Remote working/work at home options are available for this role.

Overview

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.

Responsibilities

• 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

Qualifications

• 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

Remote working/work at home options are available for this role.

Overview

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.

Responsibilities

• 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.

Qualifications

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

Overview

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.

Responsibilities

• 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.

Qualifications

• 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

Overview

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.

Responsibilities

• 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.

Qualifications

• 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

Overview

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.

Responsibilities

• 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

Qualifications

• 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

When you join Sunrise Senior Living, you will be able to use your unique skills to empower residents to live longer, healthier, and happier lives. Not only will you build meaningful relationships with residents, their families, and team members alike, you will also gain joy in serving others and deep fulfillment in your work. Explore how you can follow your passions and shed light on meaningful ways to serve, grow, and shine together.

Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 8th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of.

COMMUNITY NAME

Sunrise at Montgomery Village

Job ID

2

JOB OVERVIEW

The Wellness Nurse is responsible for monitoring the health and well-being of our residents and provides leadership support and assistance with resident care and services. Responsibilities include but are not limited to overall well-being of our residents, assisting in training and monitoring of medication care administration, communication with resident support services and families and maintaining clinical quality assurance while leading and demonstrating the Mission for Sunrise Senior Living, "to champion the quality of life for all seniors" in accordance with federal, state/provincial, and local standards and Sunrise Senior Living policies to promote the highest degree of quality care and services to our residents.

RESPONSIBILITIES & QUALIFICATIONS

Job Description

Essential Duties

As a part of the Sunrise team, supporting our Mission, Principles of Service and Core Values is a fundamental part of this job. Our foundational belief is the sacred value of human life. The unique responsibilities for this role include but are not limited to the essential functions listed as follows:

Coordination of Health Needs:

• 
  
• Identify on-going needs and services of residents in promotion of the highest quality resident services to be delivered.
  
• Ensure proper follow through, assessment, and documentation for residents with a change in health care services and status.
  
• Assist Resident Care Director (RCD) in conducting resident assessments at time of move in, 30 days post move in, semi-annually and with any change in status.
  
• Conduct monthly wellness visits for all residents.
  
• Assess, monitor, and follow up with residents who have experienced any fall, accident, or incident and document and report as required and directed.
  
• Document all pertinent information in the resident wellness file.
  
• Maintain communications with resident's family and or responsible party to ensure medical needs for the resident are being met.
  
• Contact resident's attending physician when necessary and/or upon family request.
  
• Ensure weights and vital signs are obtained monthly for each resident.
  
• Assist in maintaining wellness files according to Sunrise policies and federal and state/provincial regulations.
  
• Maintain medical supplies and emergency kits for the community.
  
• Provide clinical support and assistance to community team members as needed.
  
• Understand and follow infection control practices.
  
• Partner with the RCD and community team to promote infection control standards including any resident testing, training, and skills checks.
  
• Understand and practice the proper method of attending to and disposing of and the possibility of exposure to blood borne pathogens, bodily fluids, infectious waste, sharp sticks, and hazardous materials in compliance with universal care precautions.
  

Medication Programs

• 
  
• Monitor each resident's medication and treatment profile regularly to ensure each medication and treatment is administered as ordered and documented accurately.
  
• Transcribe physician orders Medication Administration Record Treatment Administration Record (MAR/TAR) to include initials, date and time 'noted' and, date faxed to pharmacy accurately and promptly.
  
• Complete MAR/TAR audit each month.
  
• Demonstrate and is knowledgeable of the Six (6) Rights of Medication Pass ("Right" resident, medication, dosage, time, route, right to refuse).
  
• Act as liaison for pharmacy services to ensure effective services for residents.
  
• Monitor the Medication Room, medication carts, and treatment carts for neatness, cleanliness, availability of medications, and expired medications.
  
• Complete Medication Observations and skills checks for medication care managers at the direction of the RCD.
  

Quality Assurance and Regulatory Compliance

• 
  
• Demonstrate and is knowledgeable in the following key quality improvement areas:
  
  • 
    
  • Resident Centered Care Model
    
  • APIE
    
  • Quality Care Indicators and Outcomes
    
  • Actively participates in Sunrise Quality Assurance Meetings and Clinical Meetings
    
  
  
  
• Demonstrate and is knowledgeable in the following key regulations:
  
  • 
    
  • All Federal, State/Provincial, and Local resident care and services regulations
    
  • Resident Rights
    
  • Resident Assessment/Evaluation process in accordance with state/provincial regulatory requirements.
    
  
  
  
• Review Physician Reports of all new residents as directed by RCD.
• Order medications and equipment as directed by RCD.
  
• Demonstrate and is knowledgeable of Sunrise practices and guidelines in accordance with resident care programs to include skin, nutrition, behavior, falls, and bowel/bladder.
  
• Assist in implementation, training, and monitoring of documentation related to resident's clinical health and wellness.
  
• Ensure resident changes, concerns, and/or solutions are reported to RCD as appropriate.
  
• Contribute to the overall engagement programs and processes (customer and team member engagement) including participating in the team member engagement survey and engagement improvement planning workshops.
  
• Attend regular meetings; Town Hall, Department Team, Cross Over, and others as directed by the Supervisor/Department Coordinator.
  
• Maintain compliance in assigned required training and all training required by state/province or other regulating authorities as applicable to this role to ensure that Sunrise standards are always met.
  
• Perform other duties as assigned.
  

Core Competencies

• 
  
• Ability to handle multiple priorities
  
• Possess written and verbal skills for effective communication and the ability to teach and guide team members to provide quality clinical care
  
• Competent in organizational and time management skills
  
• Demonstrate good judgment, problem solving and decision-making skills
  

Experience and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed throughout this job description are representative of the knowledge, skills, and abilities required.

• 
  
• Graduate of approved college/school of nursing
  
• Maintains a current state/provincial license as a professional Registered Nurse (RN)
  
• Minimum of one (1) year experience in home health, assisted living, hospital, or long-term care environment
  
• Demonstrates knowledge of nursing practices, techniques and methods applied to health and wellness resident care, and federal, state/provincial, and local regulations
  
• Demonstrates knowledge of good assessment skills
  
• Demonstrates proficiency in computer skills, Microsoft Office (Windows, Outlook, Excel) and Sunrise applications with the ability to learn new applications
  
• Ability to work weekends, evenings, and flexible hours to be available to our customers at peak service delivery days and times
  

ABOUT SUNRISE

Ready to take the next step and make a bigger impact than you ever imagined? As part of our team, you will help brighten the future for everyone at Sunrise and beyond. That is why we make it a priority to celebrate the unique ways you bring moments of togetherness and joy to everyone you serve. And when combined with the support, benefits, and growth opportunities we offer, the result is a career that PositivelyShines with everything you need to reach your goals - at work and in your life.

We also offer benefits and other compensation that include:

• Medical, Dental, Vision, Life, and Disability Plans
• Retirement Savings Plans
• Employee Assistant Program / Discount Program
• Paid time off (PTO), sick time, and holiday pay
• myFlexPay offered to get paid within hours of a shift
• Tuition Reimbursement
• In addition to base compensation, Sunrise may offer discretionary and/or non-discretionary bonuses. The eligibility to receive such a bonus will depend on the employee's position, plan/program offered by Sunrise at the time, and required performance pursuant to the plan/program.
• Some benefits have eligibility requirements

Apply today to learn why Sunrise Senior Living is a certified Great Place to Work®

PRE-EMPLOYMENT REQUIREMENTS

Sunrise considers the health and safety of its residents, family members, and team members among its highest priorities. Employment with Sunrise is contingent upon completing and passing a drug test (which does not include marijuana) and Tuberculosis Test, and a physical evaluation and a background check where required. Covid-19 and Influenza vaccination may be required if mandated by applicable federal, state, and local laws and authorities.

COMPENSATION DISCLAIMER

Selected candidates will be offered competitive compensation based on geographic location of community/office, skills, experience, qualifications, and certifications/licenses (where applicable).