Manager, Clinical Study Lead
Core
Manage global execution of smaller or less complex clinical trials from design through close-out, ensuring adherence to SOPs and ICH/GCP guidelines.
Role type
Manager, Clinical Study Lead
Builds
Clinical trials for Regeneron
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Global clinical trial operations, protocol development, ICH/GCP regulatory knowledge, project management, cross-functional team leadership, budget management, vendor management, trial management systems proficiency
Preferred skills
Process improvement, site evaluation and selection, patient recruitment strategies, risk assessment and mitigation
Technologies
CTMS, TMF, IVRS/IWRS, EDC, Microsoft Project, PowerPoint, Word, Excel
Responsibilities
Lead cross-functional study teams and oversee execution against timelines and budget; provide operational input into protocol development and feasibility assessments; oversee study documentation and system maintenance; manage vendor engagement and contracting; develop and manage baseline budgets and timelines; lead risk assessment and patient recruitment strategies; manage study close-out activities; supervise Clinical Study Management staff.
Seniority
Manager, direct leadership & oversight
