Clinical Trials Operations Specialist

BioSpace; New Jersey; Hybrid; USD 94,000 - 153,000; Full time

Job summary

Regeneron seeks a Clinical Study Specialist to support trial teams from site activation through close-out. You will provide technical and administrative support within the Clinical Trial Management team, coordinating with leads, CROs, and sites to keep studies on track.

The role offers on-site work with hybrid flexibility at locations in NY/NJ, and emphasizes data integrity and timely reporting to support life-changing medicines.

Qualifications

• Bachelor's degree with 2+ years of industry-related work experience in a clinical setting.

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.
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) 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 as needed.

Skills

Attention to detail

Time management

Communication skills

Team collaboration

Education

Bachelor's degree

Tools

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Job description

Regeneron seeks a Clinical Study Specialist to support trial teams from site activation through close-out. You will provide technical and administrative support within the Clinical Trial Management team, coordinating with leads, CROs, and sites to keep studies on track.

The role offers on-site work with hybrid flexibility at locations in NY/NJ, and emphasizes data integrity and timely reporting to support life-changing medicines.