Prometheus Federal Services (PFS) is seeking an experienced Clinical Trials Program Manager to lead decentralized clinical trials (DCTs) in support of the Veterans Health Administration (VHA). The role blends strategic oversight with hands-on study coordination, ensuring regulatory and ethical compliance and advancing scalable decentralized research models. The incumbent will advise government and industry stakeholders, oversee complex clinical research activities, and contribute to protocol development, regulatory submissions, sponsor engagement, and day-to-day trial operations.
Responsibilities include: leading DCT data auditing and end-to-end study coordination; facilitating cross-functional meetings with internal teams and external stakeholders (including FDA representations, industry sponsors, and VA research groups); authoring and reviewing DCT documentation such as VA IRB and ORD SOPs, training webinars, CCRS reports, executive presentations, and stakeholder engagement sessions; identifying and onboarding new DCT opportunities; developing and negotiating study protocols and agreements (budgets, CDAs, SOWs, CRADAs, TSAs); coordinating regulatory submissions, patient screening/enrollment, data entry, and overall study management; guiding participant engagement and adherence to protocol; leading study team meetings; monitoring performance metrics and ensuring compliance with VA, FDA, and Good Clinical Practices.
Qualifications: Bachelor's degree required; Master's or Nursing degree preferred. VA clinical research coordination experience with oncology experience prefer
Prometheus Federal Services (PFS) is seeking an experienced Clinical Trials Program Manager to lead decentralized clinical trials (DCTs) in support of the Veterans Health Administration (VHA). The role blends strategic oversight with hands-on study coordination, ensuring regulatory and ethical compliance and advancing scalable decentralized research models. The incumbent will advise government and industry stakeholders, oversee complex clinical research activities, and contribute to protocol development, regulatory submissions, sponsor engagement, and day-to-day trial operations.
Responsibilities include: leading DCT data auditing and end-to-end study coordination; facilitating cross-functional meetings with internal teams and external stakeholders (including FDA representations, industry sponsors, and VA research groups); authoring and reviewing DCT documentation such as VA IRB and ORD SOPs, training webinars, CCRS reports, executive presentations, and stakeholder engagement sessions; identifying and onboarding new DCT opportunities; developing and negotiating study protocols and agreements (budgets, CDAs, SOWs, CRADAs, TSAs); coordinating regulatory submissions, patient screening/enrollment, data entry, and overall study management; guiding participant engagement and adherence to protocol; leading study team meetings; monitoring performance metrics and ensuring compliance with VA, FDA, and Good Clinical Practices.
Qualifications: Bachelor's degree required; Master's or Nursing degree preferred. VA clinical research coordination experience with oncology experience prefer
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