Global Clinical Study Lead & Delivery Manager

BioSpace; Warren; On-site; GBP 95,000 - 155,000; Full time

Job summary

Regeneron seeks a Manager, Clinical Study Lead to oversee the global execution of assigned trials, from design through close-out, ensuring timelines, budgets, and conduct align with SOPs and ICH/GCP. This role includes oversight of CROs and vendor management, with a focus on continuous process improvement.

The position requires leading cross-functional teams, protocol input, site selection, and monitoring plans, while contributing to study documentation and reports.

Qualifications

• Six years of relevant industry experience with a Bachelor's degree.
• Extensive budget management and proven vendor management experience.
• Strong proficiency with trial management systems and Microsoft Office tools (Project, PowerPoint, Word, Excel).
• Experience in global clinical trial operations with ICH/GCP knowledge.
• Ability to drive operational strategy for complex studies and lead cross-functional teams.
• Experience with Phase IV / Real World Evidence is preferred.

Responsibilities

• Lead the cross-functional study team responsible for clinical study delivery and oversight.
• Oversee execution against timelines, deliverables, and budget; raise issues to leadership.
• Provide input into protocol development and site evaluation/selection; coordinate investigator meetings.
• Maintain study documentation (CRFs, data management plan, monitoring plan, TMF).
• Manage study systems (CTMS, TMF) and ensure regulatory compliance.
• Identify outsourcing needs; manage CROs and vendors per scope of work.
• Contribute to baseline budget/timeline development and change control.
• Lead study-level risk assessment, recruitment strategies, and data quality monitoring.
• Oversee study close-out activities and contribute to study reports.

Skills

Budget management

Vendor management

Project management

Cross-functional leadership

ICH/GCP knowledge

MS Office proficiency

Trial management systems

IVRS/IWRS

EDC

Education

Bachelor's degree

Tools

Trial management systems

IVRS/IWRS

EDC

TMF

CTMS

Job description

Regeneron seeks a Manager, Clinical Study Lead to oversee the global execution of assigned trials, from design through close-out, ensuring timelines, budgets, and conduct align with SOPs and ICH/GCP. This role includes oversight of CROs and vendor management, with a focus on continuous process improvement.

The position requires leading cross-functional teams, protocol input, site selection, and monitoring plans, while contributing to study documentation and reports.