Clinical Trial Operations Specialist: Site & Data Mastery

Regeneron Pharmaceuticals, Inc.; Armonk (NY); Hybrid; USD 94,000 - 153,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a Clinical Study Specialist to join our Clinical Trial Management team.

You will provide technical and administrative support to clinical study teams executing trials from site activation through close-out, collaborating with Clinical Study Leads, Associate Managers, CROs, and study sites. The role requires a Bachelor's degree with 2+ years in a clinical setting, familiarity with trial management systems and MS applications, and strong attention to detail

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
• ICH/GCP awareness
• 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 reviews study documents and reference materials.
• Tracks site activation, enrollment, and monitoring visits against plans and monitors status.
• Ensures timely receipt of scheduled reports and performs TMF reconciliations.
• Communicates with sites and maintains strong relationships internally and externally.
• Supports close-out activities and oversight of third-party vendors.
• Shows attention to detail and proactive problem-solving in assigned study activities.

Skills

Attention to detail

Problem solving

Organizational skills

Deadline management

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals, Inc. seeks a Clinical Study Specialist to join our Clinical Trial Management team.

You will provide technical and administrative support to clinical study teams executing trials from site activation through close-out, collaborating with Clinical Study Leads, Associate Managers, CROs, and study sites. The role requires a Bachelor's degree with 2+ years in a clinical setting, familiarity with trial management systems and MS applications, and strong attention to detail