Clinical Study Specialist in Cambridge

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.

Location: Armonk, NY, Warren, NJ, Cambridge, MA

Work Model: Primarily on-site with hybrid flexibility

Discover your role:

• 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.

This role requires:

• 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.

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, 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.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.