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