Global Site Start-Up Lead — Remote

BioSpace; United States; Remote; USD 134,000 - 219,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to drive strategic execution of site and country start-up activities for complex global trials. You will partner with Clinical Operations, Regulatory Affairs, CROs, and teams to accelerate study activation while maintaining high-quality, compliant processes.

The role requires 8+ years in pharma/biotech, strong ICH-GCP knowledge, and demonstrated leadership of cross-functional teams and vendors.

Qualifications

• Bachelor's degree required; 8+ years in pharma/biotech/clinical research.
• Extensive experience leading global clinical trial start-up activities including country/site activation.
• Strong knowledge of ICH-GCP guidelines and global study start-up processes.
• Proven ability to lead cross-functional teams and manage vendors/CROs.
• Excellent project management, negotiation, and risk management skills.

Responsibilities

• Develop and execute global site and country start-up strategies for complex trials, identifying risks and mitigations.
• Lead site activation planning and forecasting to meet study milestones.
• Collaborate with Clinical Operations, Regulatory Affairs, CROs, and stakeholders to drive start-up execution.
• Monitor start-up metrics and use data trends to inform decisions.
• Oversee site activation activities, including regulatory document collection and milestone tracking.
• Provide leadership to CRO partners and internal teams to ensure compliant delivery.
• Serve as primary escalation point for start-up challenges and drive cross-functional alignment.
• Lead and develop Site Start-Up professionals through coaching and performance management.

Skills

Project management

Cross-functional leadership

Regulatory affairs

Vendor management

Communication

Risk management

Education

Bachelor's degree

Job description

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to drive strategic execution of site and country start-up activities for complex global trials. You will partner with Clinical Operations, Regulatory Affairs, CROs, and teams to accelerate study activation while maintaining high-quality, compliant processes.

The role requires 8+ years in pharma/biotech, strong ICH-GCP knowledge, and demonstrated leadership of cross-functional teams and vendors.