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Contract Senior Clinical Trial Manager

8+ years
$120,000 – $160,000 USD per year
10 July 31, 2025
Job Description
Job Type: Full Time Education: BS/BA Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.