Lead Clinical Trials Program Manager

Prometheus Federal Services (PFS)

Clinical trials program manager leading decentralized research for federal health agencies and the Veterans Health Administration. Overseeing protocols, regulatory compliance, sponsors, patients, and study operations.

Posted 8/5/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $170,000 - $200,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Decentralized Clinical Trial management, including regulatory compliance, study protocol development, and cross-functional collaboration. Proficient in synthesizing research data and communicating findings to diverse stakeholders while ensuring adherence to VA, FDA, and GCP standards.

Highest-signal resume keywords

Decentralized Clinical Trial ManagementClinical Research Regulatory ComplianceStudy Protocol DevelopmentREDCap Data ManagementOncology Research Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research CoordinationRegulatory SubmissionsData EntryStudy Design TranslationBudget NegotiationPatient ScreeningStudy Performance MonitoringResearch Agreement DevelopmentAudit-Ready Record MaintenanceResearch Documentation Authoring

Soft Skills

Organizational SkillsInterpersonal SkillsWritten Communication SkillsOral Communication SkillsAnalytical Skills

Tools & Technologies

Electronic Medical Records (EMR/EHR)REDCap

Industry Keywords

VA Clinical ResearchOncology ResearchFederal ComplianceEthical Research StandardsCross-Functional Collaboration

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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