Clinical Study Specialist (Internal Medicine)
Regeneron Pharmaceuticals
Summary
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.
Job description
When & where
- Location: Armonk, NY or Warren, NJ
- Work Model: Primarily on-site with hybrid flexibility
Discover your role
- 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
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
Requirements
- 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
Benefits
- Annual bonuses
- Incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Medical insurance
- Dental insurance
- Vision insurance
- Life and disability insurance
- Paid time off
- Family support benefits
Company overview
Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.