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Clinical Study Specialist

Job in Warren, Somerset County, New Jersey, 07059, USA
Listing for: Regeneron
Full Time position
Listed on 2026-08-31
Job specializations:
  • Healthcare
    Healthcare Compliance, Clinical Research
Job Description & How to Apply Below
Location: Warren

Clinical Study Specialist

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Clinical Study Specialist to join our Clinical Trial Management team, supporting our clinical trial execution in a hybrid role. In this role, you will provide technical and administrative study support while collaborating with clinical study teams, sites, and third-party vendors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:
Uxbridge (Hybrid)

Discover your role:

  • Deliver analysable study reports and metrics to the Clinical Study Lead.
  • Coordinate study meetings, agendas, presentations, minutes, training materials, and investigator meetings.
  • Collate feasibility and site-selection data, including site usability database reviews.
  • Facilitate document reviews and maintain version-controlled regulatory, pharmacy, and laboratory manuals.
  • Track site activation, enrolment, monitoring visits, registry postings, and scheduled compliance reports.
  • Reconcile the Trial Master File and track close-out documents, product reconciliation, and CRA visits.
  • Maintain SharePoint sites, site contacts, BDRM line listings, and third-party vendor oversight.
  • You proactively identify issues, escalate delays, and recommend departmental process improvements.

This role requires:

  • Bachelor's degree or five years of relevant experience.
  • At least two years of industry-related experience.
  • An advanced related degree with one to two years of relevant experience is preferred.
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