Global Oncology Clinical Study Lead Manager

Regeneron Pharmaceuticals, Inc; Cambourne; On-site; GBP 112,000 - 142,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to oversee the global execution of assigned clinical trials from design through closeout. You will manage timelines, budgets, and ensure conduct aligns with SOPs and ICH/GCP, coordinating with CROs and internal teams.

The role involves leading cross-functional teams, overseeing study documentation and systems (CTMS, TMF), and driving process improvements to advance Regeneron's clinical program.

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management experience and vendor management skills.
• Proficiency with trial management systems and MS Office (Project, PowerPoint, Word, Excel).
• Experience in global clinical trial operations; knowledge of ICH/GCP and regulatory guidelines.
• Strong project management and cross-functional leadership abilities.

Responsibilities

• Lead cross-functional study team and ensure delivery against timelines, scope and budget.
• Provide input on protocol development; lead feasibility assessments and site selection; oversee investigator meetings.
• Oversee study documentation including CRFs, data management and monitoring plans, and TMF materials.
• Oversee setup and maintenance of study systems (CTMS, TMF) and ensure registry compliance.
• Identify outsourcing needs and manage CRO/vendor engagement and contracts; ensure alignment with scope of work.
• Monitor progress and drive continuous improvement in CTM SOPs.

Skills

Budget management

Vendor management

Cross-functional leadership

Project management

MS Office

Trial management systems

ICH/GCP knowledge

Global clinical operations

Protocol development

Organizational skills

IVRS/IWRS/EDC

Education

Bachelor’s degree

Tools

IVRS/IWRS

EDC

Project management software

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to oversee the global execution of assigned clinical trials from design through closeout. You will manage timelines, budgets, and ensure conduct aligns with SOPs and ICH/GCP, coordinating with CROs and internal teams.

The role involves leading cross-functional teams, overseeing study documentation and systems (CTMS, TMF), and driving process improvements to advance Regeneron's clinical program.