Sr. Manager - Clinical Trial Lead
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
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Experteer Overview
In this role you will lead end-to-end delivery of one or more clinical studies, guiding cross-functional teams to develop robust, patient-focused protocols. You will own day-to-day study management, ensure GCP compliance, and manage study budgets and risks. You’ll collaborate with SMTs to align study plans with IAP/POP, drive governance, and optimize outsourcing strategies with CRO partners. Your work supports timely, high-quality trial execution that advances Biogen’s mission in neurology and rare diseases. This position offers strategic influence, leadership across functional teams, and a focus on operational excellence.
- Compensation / Benefits
- Lead study management activities for one or more clinical studies, ensuring on-time delivery within budget
- Chair the SMT to develop scientifically robust and operationally feasible protocol concepts
- Collaborate with core SMT and program teams to align study design with IAP and POP
- Evaluate study feasibility and support protocol development using operational and scientific assessment
- Develop and maintain cross-functional operational plans and risk mitigation
- Ensure day-to-day study operations, regulatory compliance, and data integrity
- Oversee study budgets and cost drivers, with governance on budgetary stewardship
- Monitor outsourced studies, manage CRO relationships, and ensure milestones are met
- Maintain study-related plans (Monitoring Plan, Study Risk Management Plan, etc.) and governance readiness
- Drive process improvements, champion best practices, and promote cross-unit collaboration
- Tasks
- B.A. or B.Sc. in a scientific discipline
- 6+ years in clinical operations management with outsourced trials
- Strong project management, risk assessment, contingency planning, and communication skills
- Working knowledge of clinical development across trial phases and cross-functional drug development
- Expertise in GCP, ICH guidelines, and regulatory requirements
- Ability to develop and execute operational plans and manage CRO outsourcing strategies
- Familiarity with budgeting, financial management, reporting, and analysis in clinical trials
- Key requirements
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- Paid vacation and end-of-year shutdown
- Paid holidays and personal time off
- 401(k) with company match and employee stock purchase plan
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