Clinical Study Operations Specialist

Regeneron Pharmaceuticals, Inc.; Armonk (NY); Híbrido; USD 94.000 - 153.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to support trials from site activation through close-out. You will deliver technical and administrative support to clinical study teams, collaborating with Study Leads, managers, CROs, and study sites to keep programs on track.

Located in Armonk, NY or Warren, NJ, this on-site role offers hybrid flexibility. The position emphasizes data delivery, site communications, and TMF reconciliations, with a focus on ICH/GCP guidelines

Formación

• Bachelor's degree in a life sciences field with 2+ years in clinical settings.
• Ability to learn 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 able to manage deadlines and priorities.

Responsabilidades

• Organizes and delivers analyzable reports and metrics, and coordinates study team meetings, agendas, and minutes.
• Compiles data for feasibility and site selection, reviews study documents and reference materials.
• Tracks site activation, enrollment, and monitoring against plans; escalates issues as needed.
• Ensures timely receipt of scheduled reports and performs TMF reconciliations per guidance.
• Maintains site communications and strong internal/external relationships.
• Supports close-out activities and oversight of third-party vendors as needed.
• Contributes to SOP revisions and departmental initiatives; suggests process improvements.

Conocimientos

Trial management basics

MS Office proficiency

Communication with sites

Educación

Bachelor's degree in a related field

Herramientas

MS Project

PowerPoint

Word

Excel

IVRS/IWRS

EDC

TMF

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to support trials from site activation through close-out. You will deliver technical and administrative support to clinical study teams, collaborating with Study Leads, managers, CROs, and study sites to keep programs on track.

Located in Armonk, NY or Warren, NJ, this on-site role offers hybrid flexibility. The position emphasizes data delivery, site communications, and TMF reconciliations, with a focus on ICH/GCP guidelines