Clinical Trial Operations Specialist

Regeneron Pharmaceuticals, Inc; Armonk (NY, NJ); Hybrid; USD 75,000 - 105,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Armonk, NY (or Warren, NJ) seeks a Clinical Study Specialist to join our Clinical Trial Management team. You will provide technical and administrative support to study teams, helping ensure trials stay on track from site activation through close-out.

The role collaborates with Clinical Study Leads, CROs, and study sites. A bachelor’s degree and 2+ years of industry experience, plus familiarity with trial management systems and MS Office, are required.

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.

Responsibilities

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes.
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays.
• Performs TMF reconciliations and ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures).
• Communicates with sites and maintains site contact information and relationships.
• Contributes to close-out activities and oversight of third-party vendors as needed.
• Participates in SOP revisions and departmental initiatives to improve processes.

Skills

Trial management systems

MS Office

Medical terminology

ICH/GCP awareness

Deadline management

Education

Bachelor's degree in life sciences or related field

Job description

Regeneron Pharmaceuticals, Inc. in Armonk, NY (or Warren, NJ) seeks a Clinical Study Specialist to join our Clinical Trial Management team. You will provide technical and administrative support to study teams, helping ensure trials stay on track from site activation through close-out.

The role collaborates with Clinical Study Leads, CROs, and study sites. A bachelor’s degree and 2+ years of industry experience, plus familiarity with trial management systems and MS Office, are required.