Clinical Trials Program Manager

Prometheus Federal Services (PFS); Fairfax (VA); On-site; USD 170,000 - 200,000; Full time

Job summary

Prometheus Federal Services (PFS) is seeking an experienced Clinical Trials Program Manager to lead decentralized clinical trials (DCTs) for VA initiatives. The role combines strategic oversight with hands‑on coordination, supporting protocol development, regulatory submissions, and sponsor engagement.

The ideal candidate has VA research experience, strong regulatory acumen, and the ability to collaborate across multidisciplinary teams to deliver compliant clinical research programs.

Qualifications

• Bachelor's degree required; Master's or Nursing degree preferred.
• 10+ years of experience implementing and overseeing clinical research regulatory requirements.
• VA clinical research coordination experience; oncology exposure strongly preferred.
• Ability to manage multiple complex priorities with high attention to detail.
• Excellent organizational, interpersonal, and written and oral communication skills.
• Experience with electronic medical records (EMR/EHR) in clinical or research settings.
• Ability to work independently in a lead role while collaborating with multidisciplinary teams.
• Strong analytical and problem-solving skills for regulatory and operational challenges.
• Hands-on REDCap experience for data capture and management.
• Ability to obtain a public trust in the United States.

Responsibilities

• Lead DCT data auditing, oversight, and end‑to‑end study coordination to ensure data integrity and protocol adherence.
• Facilitate cross‑functional meetings with internal teams and external stakeholders (FDA, sponsors, VA groups) to advance DCT initiatives.
• Contribute to high‑impact DCT documentation and deliverables (IRB/ORD SOPs, reports, slide decks, stakeholder sessions).
• Engage sponsors to identify, evaluate, and onboard new DCT opportunities; translate concepts into study designs.
• Develop and negotiate study protocols and research agreements (SOWs, CDAs, TSAs, CRADAs).
• Oversee daily clinical research operations (regulatory submissions, patient screening/enrollment, data entry).
• Guide patients through study participation, ensuring protocol compliance and engagement.
• Plan and lead study team meetings; drive milestones and accountability.
• Monitor study performance with PI to ensure timely regulatory obligations.
• Maintain compliance with VA, FDA, and GCP standards throughout the lifecycle.
• Maintain complete audit-ready research records per VA/FDA standards.
• Synthesize research progress and risks for sponsors and senior stakeholders.

Skills

VA coord

Regulatory compliance

Cross-functional leadership

EMR/EHR experience

Analytical problem‑solving

Education

Bachelor's degree

Master's degree in a related field

Nursing degree preferred

Tools

REDCap

EMR/EHR systems

Job description

Position Summary

Prometheus Federal Services (PFS) is a trusted partner to federal health agencies. We are exploring the addition of an experienced Clinical Trials Program Manager to provide leadership in planning, coordinating, and executing decentralized clinical trials (DCTs) in support of the Veterans Health Administration (VHA). The Clinical Trials SME will serve as a trusted advisor to government and industry stakeholders, overseeing complex clinical research activities, ensuring regulatory and ethical compliance, and advancing scalable decentralized research models. This role combines strategic oversight with hands‑on study coordination, supporting protocol development, regulatory submissions, sponsor engagement, and day‑to‑day execution of clinical studies. The ideal candidate brings deep experience within VA research environments, strong regulatory acumen, and the ability to collaborate across multidisciplinary teams to deliver high‑quality, compliant clinical research initiatives.

Essential Duties and Responsibilities

• Lead and execute Decentralized Clinical Trial (DCT) data auditing, oversight, and end‑to‑end study coordination to ensure data integrity and protocol adherence
• Direct and facilitate cross‑functional meetings with internal teams, and external stakeholders, including FDA representatives, industry sponsors, and VA research groups, to advance DCT initiatives
• Author, review, and contribute to high‑impact DCT documentation and deliverables, including VA Institutional Review Board (IRB) and Office of Research and Development (ORD) Standard Operating Procedures, training webinars, Centralized Clinical Research System (CCRS) reports, executive‑level slide decks, and stakeholder engagement sessions
• Engage with sponsors to identify, evaluate, and onboard new DCT opportunities, translating research concepts into executable study designs
• Develop and negotiate study protocols and research agreements, including budgets, Confidential Disclosure Agreements (CDAs), Statements of Work (SOWs), Cooperative Research and Development Agreements (CRADAs), and Tele‑Health Service Agreements (TSAs) for new studies
• Oversee and coordinate daily clinical research operations, including regulatory submissions, patient screening and enrollment, data entry, and comprehensive study management
• Support and guide patients through study participation activities, ensuring protocol compliance, accessibility, and participant engagement
• Plan, organize, and lead study team meetings, driving alignment, accountability, and progress toward key milestones
• Monitor study performance metrics and collaborate closely with Principal Investigator (PIs) to ensure timeliness, deliverables, and regulatory obligations are met
• Enforce adherence to federal, VA, and ethical research regulations, maintaining continuous compliance throughout the study lifecycle
• Maintain complete, accurate, and audit‑ready research records in accordance with VA, FDA, and Good Clinical Practices (GCP) standards
• Synthesize and communicate research progress, risks, and findings to sponsors, investigators, and senior stakeholders

Minimum Qualifications

• Bachelor's degree required; Master's degree or Nursing degree preferred
• Demonstrate experience in VA clinical research coordination, with oncology research experience strongly preferred
• Minimum of ten (10) years of experience implementing and overseeing clinical research regulatory requirements
• Proven ability to manage multiple complex priorities with a high level of attention to detail and accuracy
• Exceptional organizational, interpersonal, and written and oral communication skills
• Experience working with electronic medical records (EMR/EHR) systems in clinical or research settings
• Ability to operate independently in a lead role while collaborating effectively within multidisciplinary teams
• Strong analytical and problem‑solving skills, with the ability to resolve regulatory and operational challenges
• Hands‑on experience with REDCap for clinical research data capture and management
• Ability to work in the U.S. indefinitely without sponsorship
• Ability to obtain a public trust

Compensation & Benefits

PFS offers a benefits package that may include health, dental, and vision coverage; flexible spending accounts; disability and life insurance; a retirement plan; paid time off; and other programs to support employees and their families.Learn moreabout PFS Benefits.

The posted salary range is the company’s good‑faith estimate for this role. PFS benefits and compensation are determined by various factors, including, but not limited to, location; the individual's particular combination of education, knowledge, skills, competencies, and experience; as well as contract and organizational requirements.

Salary Range $170,000 - $200,000