Clinical Trial Operations Specialist

BioSpace; Armonk (NY); On-site; USD 94,000 - 153,000; Full time

Job summary

Regeneron seeks a Clinical Study Specialist to join our Clinical Trial Management team, providing technical and administrative support across trials from site activation to close-out. You will collaborate with Clinical Study Leads, managers, CROs, and study sites to keep studies on track.

The role involves organizing reports, data collation for feasibility, tracking enrollment, maintaining TMF, and supporting vendor oversight.

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.
• 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 analyzable 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 as needed.
• Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities.
• Participates in SOP revisions and departmental initiatives, recommending process improvements.

Skills

Attention to detail

Deadline management

Education

Bachelor's degree

Tools

MS Office (Project, PowerPoint, Word, Excel)

IVRS/IWRS

EDC

TMF

Job description

Regeneron seeks a Clinical Study Specialist to join our Clinical Trial Management team, providing technical and administrative support across trials from site activation to close-out. You will collaborate with Clinical Study Leads, managers, CROs, and study sites to keep studies on track.

The role involves organizing reports, data collation for feasibility, tracking enrollment, maintaining TMF, and supporting vendor oversight.