Clinical Trial Operations Specialist (Hybrid)

Regeneron Pharmaceuticals, Inc; Uxbridge; Hybrid; GBP 42,000 - 64,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc is seeking a Clinical Study Specialist to support 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.

Key duties include delivering analysable study reports, coordinating meetings, and maintaining regulatory manuals. A Bachelor’s degree or five years of relevant experience is required, with an emphasis on two years

Qualifications

• Bachelor’s degree or five years of relevant experience.
• At least two years of industry-related experience.
• Advanced related degree 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.
• Identify issues, elevate delays, and recommend process improvements.

Skills

Clinical study coordination

Document management

Regulatory/compliance awareness

Education

Bachelor’s degree

Advanced related degree (preferred)

Five years of relevant experience (alternative)

Job description

Regeneron Pharmaceuticals, Inc is seeking a Clinical Study Specialist to support 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.

Key duties include delivering analysable study reports, coordinating meetings, and maintaining regulatory manuals. A Bachelor’s degree or five years of relevant experience is required, with an emphasis on two years