Senior Clinical Study Lead (CSL)
The Senior Clinical Study Lead is a highly independent role responsible for the global execution of large and complex clinical trials from study design through execution to close out.
This individual is accountable for study timelines, budget, and ensuring conduct aligns with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP guidelines.
The role involves leading cross-functional study teams, providing operational input into protocol development, and overseeing documentation creation, including case report forms, data management plans, and monitoring plans.
Key responsibilities include setting up and maintaining study systems, ensuring compliance with clinical trial registry requirements, identifying outsourcing needs, managing vendors, and overseeing risk assessment and mitigation strategies.
The Senior CSL must have advanced expertise in operational strategic direction, expert knowledge of clinical trial operations, and strong communication skills. They must be able to influence stakeholders, manage budgets, and build productive study teams.
Line management responsibilities include work assignments, performance management, staff recruitment, and ongoing training. The ideal candidate will possess a Bachelor's degree with a minimum of 8 years of relevant industry experience or an advanced degree in lieu of experience.