Global Site Start-Up Lead: Strategy & Activation

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

Job summary

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to join our Global Development team, overseeing strategic execution of site and country start-up activities across our clinical portfolio and supporting efficient study activation.

You will partner with Clinical Operations, Regulatory Affairs, CROs, and internal teams to drive activation planning, forecasting, risk mitigation, and milestone tracking while ensuring compliance with ICH-GCP and regulatory requirements, enabling timely

Qualifications

• Bachelor's degree plus 8+ years in pharmaceutical/clinical research.
• Experience leading global site start-up activities.
• Strong knowledge of ICH-GCP and regulatory requirements.
• Proven ability to manage vendors and CROs.
• Excellent project management and communication skills.

Responsibilities

• Develop and execute global site and country start-up strategies.
• Lead site activation planning and forecasting.
• Partner with Clinical Operations, Regulatory Affairs, CROs, and stakeholders to drive start-up execution.
• Monitor start-up metrics and drive performance improvements.
• Provide leadership to CRO partners and internal teams to ensure high-quality start-up delivery.
• Serve as escalation point for start-up challenges.

Skills

Cross-functional leadership

Program management

Risk management

Stakeholder management

Education

Bachelor's degree

Job description

Regeneron is seeking a Senior Manager, Global Site Start-Up Lead to join our Global Development team, overseeing strategic execution of site and country start-up activities across our clinical portfolio and supporting efficient study activation.

You will partner with Clinical Operations, Regulatory Affairs, CROs, and internal teams to drive activation planning, forecasting, risk mitigation, and milestone tracking while ensuring compliance with ICH-GCP and regulatory requirements, enabling timely