Contract Senior Clinical Trial Manager
Location: United States (Remote)
Work Type: Full-time (Contract)
Company: ProPharma
Industry: Pharmaceutical / Biotech / Clinical Research
Job Description:
ProPharma is hiring a Contract Senior Clinical Trial Manager to lead and oversee all phases of clinical trials—from initiation to close-out. You will play a central role in the planning, execution, and monitoring of complex and global studies including extension trials, post-trial access programs, and late-phase studies. This position offers an exciting opportunity to work across cross-functional teams, manage vendors, and ensure regulatory compliance, quality assurance, and on-time delivery of clinical programs.
Key Responsibilities:
Clinical Trial Execution & Oversight:
Lead study planning, start-up, maintenance, and close-out activities.
Manage trial timelines, budgets, priorities, and quality metrics.
Oversee vendor selection, coordination, monitoring, and compliance.
Evaluate and select investigative sites; manage feasibility and recruitment planning.
Develop trial documentation: Protocols, CRFs, ICFs, CSRs, and regulatory forms.
Maintain Trial Master File (TMF) and perform periodic QC and completeness checks.
Ensure adherence to GCP, ICH, and local/international regulations.
Provide leadership to cross-functional study teams and serve as key program contact.
Operational Leadership & Risk Management:
Drive proactive risk identification and mitigation strategies.
Lead quality-by-design efforts and inspection readiness initiatives.
Monitor site performance and implement corrective actions where needed.
Serve as the escalation point for protocol compliance and operational challenges.
Coordinate with Independent Safety Committees when required.
Data & Reporting:
Support data review, discrepancy resolution, and interim/final analysis.
Generate reports on trial progress, key metrics, and compliance status.
Ensure trial systems are updated and maintained throughout the study lifecycle.
Team & Process Improvement:
Mentor team members and lead cross-functional trial meetings.
Contribute to departmental process improvement projects.
Participate in audits and collaborate with QA during site/vendor evaluations.
Required Qualifications:
Bachelor's degree in a life science or related field (advanced degree preferred).
8+ years of clinical research experience in the biopharma industry.
Extensive experience managing global, multi-phase clinical trials from start to close.
Strong knowledge of ICH-GCP guidelines and clinical operations regulations.
Proficiency in cross-functional project leadership and vendor management.
Experience with continued access/post-trial access programs is strongly preferred.
Excellent communication, planning, and organizational skills.
Familiarity with Lean Six Sigma methodologies is a plus.
Adaptable, detail-oriented, and capable of handling multiple priorities.
Salary Estimate:
Estimated range: $120,000 – $160,000 USD per year (based on U.S. contract-based senior clinical trial roles)
Diversity & Inclusion Commitment:
ProPharma is proud to be an Equal Opportunity Employer, committed to fostering a diverse and inclusive work environment where employees can bring their full, authentic selves to work and thrive in a culture of collaboration and respect.
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