Clinical Trial Operations Specialist

Regeneron; Uxbridge; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

Regeneron is seeking a Clinical Study Specialist to join our Clinical Trial Management team in a hybrid role at Uxbridge. You will provide technical and administrative study support while collaborating with clinical study teams, sites, and third-party vendors.

Responsibilities include delivering analysable study reports and metrics, coordinating study meetings and agendas, collating feasibility data, and supporting regulatory document reviews.

Qualifications

• 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.

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.
• You proactively identify issues, elevate delays, and recommend departmental process improvements.

Skills

Clinical study coordination

Report generation

Stakeholder collaboration

Meeting coordination

Regulatory documentation

Issue identification

Education

Bachelor's degree or 5 years experience

Advanced related degree (preferred)

Job description

Regeneron is seeking a Clinical Study Specialist to join our Clinical Trial Management team in a hybrid role at Uxbridge. You will provide technical and administrative study support while collaborating with clinical study teams, sites, and third-party vendors.

Responsibilities include delivering analysable study reports and metrics, coordinating study meetings and agendas, collating feasibility data, and supporting regulatory document reviews.