Senior Decentralized Clinical Trials Program Lead

Prometheus Federal Services (PFS); Fairfax (VA); Vor Ort; USD 170.000 - 200.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

VA coord

Regulatory compliance

Cross-functional leadership

EMR/EHR experience

Analytical problem‑solving

Ausbildung

Bachelor's degree

Master's degree in a related field

Nursing degree preferred

Tools

REDCap

EMR/EHR systems

Jobbeschreibung

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.