Job Description
Title: Senior Clinical Trial Manager (Phase II/III)
Location: Greater Boston Area, MA (Hybrid 3 days onsite)
Employment Type: Contract
Status: Accepting Candidates
About the role
This role leads complex late-phase clinical trials, partnering with cross-functional teams to ensure high-quality execution, regulatory compliance, and on-time delivery. You will play a key role in driving operational excellence across global studies.
Key Responsibilities
• Lead end-to-end Phase II/III clinical trial operations from startup through closeout
• Own CRO and vendor management, including oversight of timelines, quality, and deliverables
• Manage study budgets, forecasting, and contracts
• Ensure compliance with ICH-GCP, FDA regulations, and inspection readiness
• Drive site selection, activation, and enrollment performance
• Collaborate with regulatory, data management, clinical supply, and project management teams
Qualifications
• 8–12+ years of experience in clinical operations / clinical trial management
• Proven leadership of Phase II/III global clinical trials in pharma or biotech
• Strong expertise in vendor oversight, budget management, and CRO governance
• Deep knowledge of ICH-GCP, FDA regulations, and SOPs
• Experience supporting clinical documentation (protocols, CSRs, IBs)
• Bachelor’s degree required; advanced scientific degree preferred
Compensation (MA Pay Transparency):
• Estimated hourly range: $105–$115/hr (W-2)
• Final rate within this range will be based on skills, experience, and interview results