Clinical Trial Management Specialist

Regeneron Pharmaceuticals; Warren (MI); Híbrido; USD 94.000 - 153.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join our Clinical Trial Management team in Armonk, NY or Warren, NJ.

You will provide technical and administrative support to study teams, helping keep trials on track from site activation through close-out while collaborating with study leads, CROs, and sites. You will organize reports and metrics, track enrollment and monitoring visits, reconcile TMF documents, and support vendor oversight.

Formación

• 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.

Responsabilidades

• 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 (e.g., informed consent forms, case report forms) and reference materials (e.g., regulatory, pharmacy, laboratory binders)
• Tracks site activation, enrollment, and monitoring visits against projected plans, escalating issues or delays, and monitors investigator/site status and registry postings
• Ensures timely receipt of scheduled reports (e.g., 1572s, financial disclosures) and performs TMF reconciliations with study lead guidance
• Communicates with sites as directed, maintaining site contact information and strong relationships internally and externally
• Contributes to close-out activities (e.g., 1572s, IP reconciliation, financial disclosures, CRA close-out visits) and supports oversight of third-party vendors as needed
• Brings attention to detail, resourcefulness, and proactive problem-solving to assigned study activities, investigating impact on trials as new information arises
• Participates in SOP revisions and departmental initiatives, proactively recommending process improvements

Conocimientos

Trial management knowledge

Deadline management

Medical terminology familiarity

ICH/GCP awareness

Educación

Bachelor's degree

Herramientas

MS Office suite

TMF systems

EDC / IVRS/IWRS

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Clinical Study Specialist to join our Clinical Trial Management team in Armonk, NY or Warren, NJ.

You will provide technical and administrative support to study teams, helping keep trials on track from site activation through close-out while collaborating with study leads, CROs, and sites. You will organize reports and metrics, track enrollment and monitoring visits, reconcile TMF documents, and support vendor oversight.