Lead Clinical Trials Program Manager

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Prometheus Federal Services (PFS)

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2014

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Prometheus Federal Services (PFS) is a Service-Disabled Veteran-Owned Small Business (SDVOSB) dedicated to transforming healthcare for federal agencies. Founded in 2014, PFS leverages research and data analytics to enhance healthcare access, quality, and outcomes for Service Members, Veterans, and their families. By partnering with government entities like the Department of Veterans Affairs, PFS provides innovative solutions and strategic support in areas such as healthcare transformation, program management, and quality improvement, aiming to ensure that Veterans receive the best possible care and service.

📋 Description

• Lead and execute Decentralized Clinical Trial data auditing, oversight, and end-to-end study coordination • Direct and facilitate cross-functional meetings with internal teams and external stakeholders, including FDA representatives, industry sponsors, and VA research groups • Author, review, and contribute to DCT documentation and deliverables, including VA IRB and ORD Standard Operating Procedures, training webinars, CCRS reports, executive-level slide decks, and stakeholder engagement sessions • Engage with sponsors to identify, evaluate, and onboard new DCT opportunities • Translate research concepts into executable study designs • Develop and negotiate study protocols and research agreements, including budgets, CDAs, SOWs, CRADAs, and TSAs • Oversee 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 • Plan, organize, and lead study team meetings • Monitor study performance metrics and collaborate with Principal Investigators to meet timelines, deliverables, and regulatory obligations • Enforce federal, VA, and ethical research compliance throughout the study lifecycle • Maintain complete, accurate, and audit-ready research records under VA, FDA, and GCP standards • Synthesize and communicate research progress, risks, and findings to sponsors, investigators, and senior stakeholders

🎯 Requirements

• Bachelor's degree required • Master's degree or Nursing degree preferred • Experience in VA clinical research coordination • Oncology research experience strongly preferred • Minimum of ten (10) years of experience implementing and overseeing clinical research regulatory requirements • Ability to manage multiple complex priorities with attention to detail and accuracy • Exceptional organizational, interpersonal, written, and oral communication skills • Experience with electronic medical records (EMR/EHR) systems in clinical or research settings • Ability to operate independently in a lead role while collaborating within multidisciplinary teams • Strong analytical and problem-solving skills • 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

🏖️ Benefits

• Health, dental, and vision coverage • Flexible spending accounts • Disability and life insurance • Retirement plan • Paid time off • Other programs to support employees and their families