Note: The job is a remote job and is open to candidates in USA. Prometheus Federal Services (PFS) is a trusted partner to federal health agencies. The company is seeking an experienced Clinical Trials Program Manager to lead the planning, coordination, and execution of decentralized clinical trials supporting the Veterans Health Administration. This role provides strategic oversight and hands-on management of clinical research operations, regulatory compliance, study protocols, sponsor engagement, and multidisciplinary stakeholder collaboration.
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
Skills
- 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
- Master's degree or Nursing degree preferred
- Oncology research experience strongly preferred
Benefits
- Health, dental, and vision coverage may be included.
- Flexible spending accounts may be included.
- Disability and life insurance may be included.
- A retirement plan may be included.
- Paid time off may be included.
- Other programs to support employees and their families may be included.
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