Clinical Study Specialist

Regeneron Pharmaceuticals•Armonk, NY

2d•Hybrid

About The Position

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.

Requirements

Bachelor’s degree or five years of relevant experience.
At least two years of industry-related experience.

Nice To Haves

An advanced related degree with one to two years of relevant experience is preferred.

Responsibilities

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.
Proactively identify issues, escalate delays, and recommend departmental process improvements.