Strategic Global Clinical Study Lead

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager, Clinical Study Lead to oversee the global execution of assigned clinical trials from design through close-out. You will own timelines, budgets, and ensure SOPs and ICH/GCP compliance, coordinating with CROs as needed.

You will lead cross-functional study teams, contribute to protocol development, site selection, and study documentation, and manage CTMS/EDC systems while driving continuous process improvements.

Qualifications

• Bachelor’s degree required.
• At least six years of relevant industry experience.
• Extensive budget management expertise.
• Proven vendor management experience.
• Strong proficiency with trial management systems and MS Office.
• Deep knowledge of ICH/GCP and regulatory guidelines.
• Excellent cross-functional leadership and project management skills.

Responsibilities

• Lead the cross-functional study team and oversee delivery within timelines and budgets.
• Provide operational input into protocol development and site selection.
• Oversee study documentation and data management plans.
• Manage setup and maintenance of study systems (CTMS, TMF) and regulatory compliance.
• Identify outsourcing needs and manage CRO/vendor engagement.
• Lead risk assessment, patient recruitment strategies, and monitoring oversight.
• Supervise CTM staff and drive process improvements.
• Contribute to clinical study reports and lessons learned.

Skills

Budget management

Vendor management

Cross-functional leadership

Project management

CTMS/EDC proficiency

ICH/GCP knowledge

MS Office proficiency

Education

Bachelor’s degree

Tools

CTMS

EDC

TMF

Job description

Regeneron Pharmaceuticals is seeking a Manager, Clinical Study Lead to oversee the global execution of assigned clinical trials from design through close-out. You will own timelines, budgets, and ensure SOPs and ICH/GCP compliance, coordinating with CROs as needed.

You will lead cross-functional study teams, contribute to protocol development, site selection, and study documentation, and manage CTMS/EDC systems while driving continuous process improvements.