At a Glance
- Tasks: Support clinical trials by organising reports, coordinating meetings, and tracking study progress.
- Company: Regeneron, a science-driven organisation making a difference in patients' lives.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with opportunities for process improvement and career advancement.
- Why this job: Join a fast-growing team and contribute to life-changing medicines for serious diseases.
- Qualifications: Bachelor's degree and 2+ years in a clinical setting required.
The predicted salary is between 30000 - 40000 £ per year.
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. In this role, you will provide technical and administrative support to clinical study teams executing trials across a program, helping ensure studies stay on track from site activation through close-out, while collaborating with Clinical Study Leads, Clinical Study Associate Managers, CROs, and study sites. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Organises 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.
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.
Clinical Study Specialist in Cambourne employer: Regeneron Pharmaceuticals, Inc
At Regeneron, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that fosters innovation and collaboration. As a Senior Manager in our Global Development Quality Assurance team, you will have the opportunity to lead impactful audit strategies while working remotely from the UK or Ireland, benefiting from a comprehensive rewards package that includes competitive bonuses, health and wellness programs, and robust employee growth opportunities. Join us in making a meaningful difference in patients' lives while enjoying a supportive environment that values diversity and professional development.
Contact Details:
Regeneron Pharmaceuticals, Inc Recruitment Team
