Clinical Trial Operations Specialist

Regeneron Pharmaceuticals, Inc.; New Jersey; 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 the United States.

The role provides technical and administrative support to trials from site activation through close-out, collaborating with Clinical Study Leads, CROs, and study sites. This on-site role with hybrid flexibility requires a Bachelor's degree with 2+ years in a clinical setting and working knowledge of trial management systems and MS applications.

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
• Proactive, self-disciplined, and effective at managing deadlines and priorities

Responsibilities

• Organizes and delivers analysable 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 and reference materials
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays
• Ensures timely receipt of scheduled reports and performs TMF reconciliations with study lead guidance
• Communicates with sites and maintains site contact information and relationships
• Contributes to close-out activities and supports oversight of third-party vendors
• Brings attention to detail and proactive problem-solving to assigned study activities
• Participates in SOP revisions and departmental initiatives

Skills

MS Office

Trial management systems

Clinical research knowledge

Deadline management

Site communication

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 the United States.

The role provides technical and administrative support to trials from site activation through close-out, collaborating with Clinical Study Leads, CROs, and study sites. This on-site role with hybrid flexibility requires a Bachelor's degree with 2+ years in a clinical setting and working knowledge of trial management systems and MS applications.