Clinical Trial Operations Specialist

Regeneron Pharmaceuticals; Cambridge; On-site; GBP 71,000 - 115,000; Full time

Job summary

Regeneron Pharmaceuticals seeks a Clinical Study Specialist to support trial management from site activation to close-out. You will generate analyzable reports, manage study documents, and coordinate team meetings to keep trials on track.

This role requires a Bachelor’s degree and 2+ years of clinical experience. You will work with clinical leads, CROs, and sites, ensuring timely data, regulatory compliance, and proactive issue resolution.

Qualifications

• Bachelor's degree with 2+ years of industry-related work experience in a clinical setting.
• Ability to acquire working knowledge in trial management systems and MS applications (Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC, TMF)
• Basic familiarity with medical terms and clinical drug development.
• Awareness of ICH/GCP.
• Proactive, self-disciplined, and effective at managing deadlines and priorities.

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes.
• Collates data for feasibility and site selection assessments, and contributes to review of study documents (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
• Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
• Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed
• Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impact on trials as new information arises
• Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Skills

Trial management systems

MS Office

Medical terminology

Time management

Education

Bachelor's degree

Tools

Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals seeks a Clinical Study Specialist to support trial management from site activation to close-out. You will generate analyzable reports, manage study documents, and coordinate team meetings to keep trials on track.

This role requires a Bachelor’s degree and 2+ years of clinical experience. You will work with clinical leads, CROs, and sites, ensuring timely data, regulatory compliance, and proactive issue resolution.