Clinical Study Operations Specialist — Hybrid

BioSpace; Greater London; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

Regeneron in the UK is seeking a Clinical Study Specialist to join the Clinical Trial Management team in a hybrid role in Uxbridge. You will support trial execution, collaborate with study teams, sites, and vendors, and deliver analysable study reports to the Clinical Study Lead.

Responsibilities include coordinating meetings, maintaining regulatory and pharmacy manuals, tracking site activation and enrolment, and reconciling the Trial Master File while overseeing third‑party vendors and process

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, escape delays, and recommend departmental process improvements.

Skills

Study coordination

Regulatory docs

Data reporting

Vendor oversight

Education

Bachelor's degree

Advanced related degree

Tools

SharePoint

Job description

Regeneron in the UK is seeking a Clinical Study Specialist to join the Clinical Trial Management team in a hybrid role in Uxbridge. You will support trial execution, collaborate with study teams, sites, and vendors, and deliver analysable study reports to the Clinical Study Lead.

Responsibilities include coordinating meetings, maintaining regulatory and pharmacy manuals, tracking site activation and enrolment, and reconciling the Trial Master File while overseeing third‑party vendors and process