Global Site Activation Lead

Regeneron Pharmaceuticals, Inc.

New Jersey

Hybrid

USD 140,000 - 210,000

Full time

3 hours ago
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Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Global Site Start-Up Lead to drive global site activation for clinical trials. You will lead fast-track initiation, milestone tracking, and document collection while ensuring compliance with ICH-GCP and Regeneron SOPs.

Expect collaboration with CROs and cross-functional teams to achieve study objectives. The role requires strong leadership, risk mitigation, and data-driven decisions to optimize site activation strategies and regulatory

Qualifications

  • 7+ years of experience in biotechnology/pharmaceutical industry.
  • Masters/MBA/PharmD with 5+ years of relevant industry experience.

Responsibilities

  • Develop global site start-up strategy and dependencies; mitigate risks.
  • Lead site activation projections and track CRO performance with metrics.
  • Oversee regulatory submissions and TMF documentation for inspections.
  • Coordinate with cross-functional teams and CROs to align timelines and resources.
  • Mentor teams on regulatory requirements and site initiation processes.

Skills

Project leadership
Site start-up
Cross-functional collaboration
Regulatory submissions

Education

Masters/MBA/PharmD

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Global Site Start-Up Lead to drive global site activation for clinical trials. You will lead fast-track initiation, milestone tracking, and document collection while ensuring compliance with ICH-GCP and Regeneron SOPs.

Expect collaboration with CROs and cross-functional teams to achieve study objectives. The role requires strong leadership, risk mitigation, and data-driven decisions to optimize site activation strategies and regulatory

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