Global Site Start-Up Lead: Strategy & Execution

Regeneron Pharmaceuticals, Inc (USA)

Armonk (NY)

On-site

USD 115,000 - 187,000

Full time

7 days ago
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Job summary

Regeneron Pharmaceuticals, Inc. in Armonk, NY is seeking a Manager, Global Site Start-Up Lead to drive the global execution of site activation for clinical trials, in partnership with CROs and cross-functional teams.

You will develop site activation projections, mitigate risks, track CRO performance, and ensure timely submissions while maintaining TMF quality. This role combines strategic oversight with hands-on leadership across country start-up and site start-up activities.

Qualifications

  • Experience leading site start-up across studies.
  • Knowledge of ICH-GCP and regulatory guidelines.
  • Strong cross-functional leadership and vendor mgmt.

Responsibilities

  • Develop global site start-up strategy and projections.
  • Monitor CRO performance and site activation metrics.
  • Coordinate regulatory submissions and TMF documentation.
  • Lead fast-track initiation and milestone tracking.
  • Collaborate with CROs and cross-functional teams.

Skills

Global SSU leadership
Cross-functional collaboration
Regulatory awareness
Vendor management
Project management
Data-driven decision making

Tools

CTMS
TMF
MS Office
PowerPoint
Word
Excel

Job description

Regeneron Pharmaceuticals, Inc. in Armonk, NY is seeking a Manager, Global Site Start-Up Lead to drive the global execution of site activation for clinical trials, in partnership with CROs and cross-functional teams.

You will develop site activation projections, mitigate risks, track CRO performance, and ensure timely submissions while maintaining TMF quality. This role combines strategic oversight with hands-on leadership across country start-up and site start-up activities.

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