Global Site Start-Up Lead: Strategy & Activation Excellence

Regeneron Pharmaceuticals; Warren (MI); On-site; USD 115,000 - 187,000; Full time

Job summary

Regeneron Pharmaceuticals in Armonk, NY (with additional locations in Warren, NJ) is seeking a Manager, Global Site Start-Up Lead to drive end-to-end activation of sites for clinical trials. You will partner with CROs and cross-functional teams to develop activation strategies, track milestones, and ensure TMF documentation is inspection-ready.

The role requires leading fast-track initiation, milestone tracking, and cross-functional collaboration to meet study objectives while ensuring ICH-GCP

Qualifications

• Experience in clinical drug development with study start-up expertise.
• Strong vendor management and cross-functional leadership.
• Proven ability to manage regulatory submissions and TMF documentation.

Responsibilities

• Develop site start-up strategy and monitor study metrics.
• Lead fast-track site initiation and milestone tracking.
• Coordinate CRO partnerships and regulatory submissions.
• Ensure TMF-ready site documentation and inspection readiness.

Skills

Leadership

Cross-functional collaboration

Vendor management

Regulatory submissions

Study start-up

Tools

CTMS

TMF

PowerPoint

Word

Excel

Job description

Regeneron Pharmaceuticals in Armonk, NY (with additional locations in Warren, NJ) is seeking a Manager, Global Site Start-Up Lead to drive end-to-end activation of sites for clinical trials. You will partner with CROs and cross-functional teams to develop activation strategies, track milestones, and ensure TMF documentation is inspection-ready.

The role requires leading fast-track initiation, milestone tracking, and cross-functional collaboration to meet study objectives while ensuring ICH-GCP