Global Clinical Study Lead

Regeneron; Armonk (NY); On-site; USD 128,600 - 210,000; Full time

Job summary

Regeneron is seeking a Manager, Clinical Study Lead to drive the global execution of smaller or less complex clinical trials from design through close-out. You will own study timelines and budgets, ensuring conduct aligns with SOPs and ICH/GCP, with oversight of CROs and internal teams.

The role requires a Bachelor’s degree and at least six years of industry experience, strong trial management systems knowledge, and budgeting expertise.

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Experience managing global clinical studies and budgets.
• Strong knowledge of ICH/GCP and regulatory guidelines.
• Proven ability to lead cross-functional study teams.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery within timelines and budget.
• Provides input into protocol development and site evaluation; leads investigator meeting prep and execution.
• Oversees study documentation, data management plans, monitoring plans, and related materials.
• Manages study setup and maintenance of study systems (CTMS, TMF) and ensures regulatory compliance.
• Identifies outsourcing needs and oversees CRO/vendor engagement and budgets.

Skills

Budget management

Project management

Cross-functional leadership

Trial management systems

Microsoft Office (Project, PowerPoint,

Education

Bachelor’s degree

Tools

IVRS/IWRS

EDC

CTMS

Job description

Regeneron is seeking a Manager, Clinical Study Lead to drive the global execution of smaller or less complex clinical trials from design through close-out. You will own study timelines and budgets, ensuring conduct aligns with SOPs and ICH/GCP, with oversight of CROs and internal teams.

The role requires a Bachelor’s degree and at least six years of industry experience, strong trial management systems knowledge, and budgeting expertise.