Clinical Study Operations Specialist

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

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join the Clinical Trial Management team in a role that supports trials from site activation through close-out.

You will organize reports, coordinate meetings, and manage documentation while collaborating with study leads, CROs, and sites. A bachelor's degree with 2+ years of clinical experience and strong MS Office skills are required, along with ICH/GCP awareness.

Qualifications

• Bachelor's degree and 2+ years of industry-related work experience in a clinical setting.
• Familiarity with trial management systems and MS applications (PowerPoint, Word, Excel, Project).
• Basic familiarity with medical terms and clinical drug development.
• Awareness of ICH/GCP.
• Proactive, self-disciplined, and able to manage 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, escalating issues as needed.
• Ensures timely receipt of scheduled reports and performs TMF reconciliations with guidance.
• Communicates with sites and maintains relationships internally and externally.
• Supports close-out activities and oversight of third-party vendors as needed.
• Proactively identifies process improvements and participates in SOP revisions.

Skills

Attention to detail

Deadline management

Communication skills

Clinical trial knowledge

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join the Clinical Trial Management team in a role that supports trials from site activation through close-out.

You will organize reports, coordinate meetings, and manage documentation while collaborating with study leads, CROs, and sites. A bachelor's degree with 2+ years of clinical experience and strong MS Office skills are required, along with ICH/GCP awareness.