What are the responsibilities and job description for the Senior Manager, Clinical Study Director position at Regeneron Pharmaceuticals?
The Senior Clinical Study Lead (CSL) is a key member of the Regeneron team responsible for delivering global clinical trials. With a high degree of independence, this role oversees study timelines and ensures compliance with ICH/GCP.
Key Responsibilities:
- Leads cross-functional study teams to achieve successful trial outcomes
- Contributes to protocol development and study planning
- Oversees documentation development and review
- Ensures accurate budget management and data entry monitoring
- Identifies outsourcing needs and leads vendor engagement and contracting
- Provides input into feasibility assessments and risk mitigation strategies
This role has significant responsibilities including overseeing study execution against planned timelines and budgets, as well as supporting internal audit and external inspection activities.
Requirements:
- Exceptional leadership and interpersonal skills
- Advanced expertise in operational strategic direction and guidance
- Expert knowledge and data-driven approach to problem-solving
- Strong budget management experience
