Contract Senior Clinical Trial Manager
Location: United States (Remote)
Work Type: Full-time (Contract)
Company: ProPharma
Industry: Biopharmaceutical / Clinical Research
Job Description:
ProPharma is hiring a Contract Senior Clinical Trial Manager to oversee global clinical trials from start-up through close-out. This role is central to the planning, coordination, and delivery of complex clinical studies including extension trials, post-trial access programs, and late-phase/post-marketing trials. You will lead cross-functional teams, manage trial vendors, ensure adherence to GCP and regulatory requirements, and help drive continuous process improvement.
Key Responsibilities:
Clinical Trial Oversight:
Lead all clinical trial phases: feasibility, start-up, execution, close-out.
Ensure on-time, on-budget, and quality delivery of study milestones.
Develop trial documentation (Protocols, CRFs, ICFs, CSRs, Monitoring Plans, etc.).
Evaluate and select study sites and vendors; lead site feasibility efforts.
Review site monitoring reports; co-monitor as needed.
Oversee TMF completeness, perform QC checks, and ensure audit readiness.
Lead study meetings and manage cross-functional communications.
Operational and Regulatory Compliance:
Ensure trials adhere to GCP, ICH, SOPs, and global regulatory requirements.
Monitor investigator performance and protocol compliance.
Manage issues and escalate as needed to senior leadership.
Oversee training of CROs and vendors.
Coordinate Safety Committees and review Safety Charters.
Project and Risk Management:
Manage trial timelines, budgets, supplies, and recruitment strategies.
Identify risks and implement mitigation plans proactively.
Track study progress via systems and generate status reports for leadership.
Lead quality-by-design initiatives to minimize risk and enhance study quality.
Develop performance metrics and ensure high-quality data delivery.
Required Qualifications:
Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
Minimum 8+ years’ experience in global clinical trial management.
Proven success managing multinational study start-up, maintenance, and close-out.
Strong knowledge of ICH-GCP and regulatory standards.
Experience with post-trial access programs and vendor coordination.
Excellent leadership, planning, and team management skills.
Strong communication and stakeholder engagement abilities.
Familiarity with Lean Six Sigma is a plus.
Comfortable working in small, fast-paced organizations.
Salary Estimate:
Estimated range: $120,000 – $160,000 USD annually (based on contract clinical trial manager rates in the U.S.)
Diversity & Inclusion Commitment:
ProPharma is an Equal Opportunity Employer that celebrates diversity and inclusion. We create a safe and supportive space where all employees are empowered to be themselves, collaborate openly, and succeed together.
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