Sr Manager, Clinical Trial Lead
About The Position
The Senior Manager, Clinical Trial Lead (CTL) leads operational planning, execution, and delivery of one or more clinical studies across the development lifecycle. The role manages study timelines, budgets, CRO and vendor partnerships, risk mitigation, and cross-functional collaboration through leadership of the Study Management Team (SMT). The CTL is accountable for delivering studies on time, within budget, and in compliance with GCP, regulatory requirements, and quality standards while protecting patient safety and data integrity. As the central operational leader, the CTL drives protocol feasibility, study execution, and informed decision-making among stakeholders. The role partners closely with Medical, Biostatistics, Regulatory, Data Management, and external partners to support program and asset strategies. The position may be based in Cambridge, Massachusetts, or RTP, North Carolina.
Requirements
- Bachelor’s degree in a scientific discipline.
- At least 6 years of experience in clinical operations management overseeing outsourced clinical trials against quality, timeline, and budget expectations; experience with a sponsor company and a CRO is preferred.
- Scientific and clinical expertise, with strong project management, risk assessment, contingency planning, and communication skills.
- Working knowledge of clinical development across Phase I–IV studies and cross-functional drug development.
- Demonstrated experience managing CROs, vendors, and outsourced clinical trials, including governance, performance oversight, budgets, quality, and outsourcing strategies.
- Expertise in GCP, ICH guidelines, and global regulatory requirements for clinical development.
- Proven ability to develop and execute operational plans that support successful clinical trial delivery.
Nice To Haves
- Experience in Immunology, Rare Disease, or Neurology.
Responsibilities
- Lead the operational planning, execution, and delivery of one or more clinical studies.
- Chair the Study Management Team (SMT) and drive cross-functional study execution.
- Partner with Medical, Biostatistics, Regulatory, and other stakeholders to develop operationally feasible protocols and study strategies.
- Evaluate study feasibility and develop operational, monitoring, quality, and risk management plans.
- Manage study timelines, budgets, forecasts, and governance deliverables to support on-time, on-budget execution.
- Identify, assess, and mitigate operational risks while maintaining patient safety, data integrity, and regulatory compliance.
- Oversee CROs, vendors, and outsourced partnerships, including performance, milestone achievement, and issue resolution.
- Monitor study performance and conduct ongoing data reviews to identify and address quality, safety, or execution issues.
- Maintain accurate, inspection-ready study documentation and data within clinical trial management systems.
- Champion process improvements, operational excellence, and best practices across studies and development programs.
Benefits
- Medical, dental, vision, and life insurance.
- Fitness and wellness programs, including fitness reimbursement.
- Short- and long-term disability insurance.
- At least 15 days of paid vacation and end-of-year shutdown time off from December 26 through December 31.
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
- 80 hours of sick time per calendar year.
- Paid maternity and parental leave.
- 401(k) program with company-matched contributions.
- Employee stock purchase plan.
- Tuition reimbursement of up to $10,000 per calendar year.
- Employee Resource Groups participation.
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities, for eligible regular employees.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
