Clinical Trials Program Manager
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Job Description
Clinical Trials Program Manager leading decentralized clinical trials for federal health agencies and the Veterans Health Administration. Overseeing protocols, regulatory compliance, sponsors, patients, and study operations.
Responsibilities:
- 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 SOPs, 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 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 ensure timeliness, deliverables, and regulatory obligations
- Enforce federal, VA, and ethical research regulations throughout the study lifecycle
- Maintain complete, accurate, and audit-ready research records according to VA, FDA, and GCP standards
- 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 coverage
- Dental coverage
- Vision coverage
- Flexible spending accounts
- Disability insurance
- Life insurance
- Retirement plan
- Paid time off
- Other programs to support employees and their families
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