Senior Global Clinical Study Lead

Regeneron Pharmaceuticals; Cambridge; On-site; GBP 96,000 - 157,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager, Clinical Study Lead to own the global execution of smaller or less complex trials from design through close-out. You will manage timelines, budgets, and ensure SOP/ICH-GCP compliance, working with CROs as needed.

The role requires a Bachelor’s degree and at least six years in clinical operations, with strong trial management systems and MS Office skills. This on-site position emphasizes leadership, coordination, and continuous improvement.

Qualifications

• Bachelor's degree and at least six years of relevant industry experience.
• Extensive budget management expertise and vendor management experience.
• Strong technical proficiency with trial management systems and Microsoft applications (Project/PowerPoint/Word/Excel).
• Experience in global clinical trial operations and regulatory guidelines.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and oversees execution against timelines, deliverables, and budget.
• Provides operational input into protocol development and feasibility assessments; oversees site evaluation and investigator meeting execution.
• Oversees study documentation and maintenance of study systems (CTMS, TMF) ensuring compliance.
• Manages outsourcing needs, vendor engagement, contracting, and CRO oversight.
• Contributes to baseline budget and timeline development and manages scope changes for internal and external studies.
• Leads risk assessment, site activation, monitoring, recruitment strategies, and data/query resolution.
• Oversees study close-out activities, including database lock and study drug accountability.
• Assigns tasks to CTM staff and participates in process improvements; supports ongoing training and compliance.

Skills

Budget management

Vendor management

Cross-functional leadership

MS Office proficiency

Education

Bachelor's degree

Tools

IVRS/IWRS

EDC

Project

PowerPoint

Word

Excel

Job description

Regeneron Pharmaceuticals is seeking a Manager, Clinical Study Lead to own the global execution of smaller or less complex trials from design through close-out. You will manage timelines, budgets, and ensure SOP/ICH-GCP compliance, working with CROs as needed.

The role requires a Bachelor’s degree and at least six years in clinical operations, with strong trial management systems and MS Office skills. This on-site position emphasizes leadership, coordination, and continuous improvement.