Lead Clinical Trials Program Manager

Prometheus Federal Services•Fairfax, VA

1d•$170,000 - $200,000

About The Position

Prometheus Federal Services (PFS) is seeking an experienced Clinical Trials Program Manager to provide leadership in planning, coordinating, and executing decentralized clinical trials (DCTs) for the Veterans Health Administration (VHA). This role involves serving as a trusted advisor to government and industry stakeholders, overseeing complex clinical research, ensuring regulatory compliance, and advancing scalable decentralized research models. The position requires a blend of strategic oversight and hands-on coordination, including protocol development, regulatory submissions, sponsor engagement, and daily execution of clinical studies. A strong background in VA research environments and regulatory acumen is essential for success in this role.

Requirements

Bachelor's degree required.
Demonstrate experience in VA clinical research coordination.
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.

Nice To Haves

Master's degree or Nursing degree preferred.
Oncology research experience strongly preferred.

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.