Clinical Study 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

Build our future together:

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, elevate 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.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.