Global Site Start-Up Lead: Strategy & Activation

Regeneron Pharmaceuticals

Armonk (NY)

On-site

USD 115,000 - 187,000

Full time

5 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Regeneron Pharmaceuticals is seeking a Manager, Global Site Start-Up Lead (SSU Lead) to drive global site activation for clinical trials. You will partner with cross-functional teams and CROs to deliver timely, compliant site initiation with strong metrics oversight and TMF documentation.

This role involves fast-track initiation, milestone tracking, and strategic country start-up planning. Key responsibilities include leading site activation projections, risk mitigation, and CRO performance

Qualifications

Proven leadership in site start-up or clinical operations.
Strong project management and cross-functional collaboration skills.
Experience with regulatory guidelines and ICH-GCP.
Vendor management and CRO oversight experience.

Responsibilities

Develop site start-up strategy and projections, mitigate risks, and track metrics.
Oversee CRO performance and implement corrective actions as needed.
Lead fast-track initiation, milestones, and document collection for TMF readiness.
Advocate for optimized site selection using data-driven insights to guide teams.
Coordinate regulatory submissions and country start-up activities with CROs and sites.
Provide training on regulatory requirements and TMF filing to teams.
Travel up to 25% as required.