Oncology Clinical Study Lead & Program Manager

Regeneron Pharmaceuticals, Inc (USA); Kentucky; Presencial; USD 129.000 - 210.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonuses or incentives

Equity awards

401(k) company match

Health and wellness programs

Pension/retirement benefits

On-site fitness centers

Paid time off

Family support benefits

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to drive end-to-end delivery of clinical studies from a leading hub in the US. The role collaborates with cross-functional teams to ensure projects stay on schedule, within budget, and compliant with ICH/GCP guidelines.

Responsibilities include protocol input, site selection, investigator meetings, and oversight of CTMS/EDC/IVRS systems, with 25% travel. On-site locations include Armonk, NY; Warren, NJ; Cambridge, MA.

Formación

• Bachelor’s degree in a scientific or healthcare field and six+ years of relevant industry experience.
• Extensive budget management expertise within clinical study operations.
• Demonstrated vendor management experience and collaboration with CROs and vendors.

Responsabilidades

• Leads cross-functional study teams and oversees delivery against timelines, deliverables, and budget.
• Provides operational input into protocol development and feasibility assessments.
• Oversees site evaluation/selection, investigator meetings, and study documentation.
• Manages study systems (CTMS, TMF) and ensures regulatory compliance and data integrity.
• Engages with outsourcing needs, vendor contracting, and management of third-party vendors.
• Leads risk assessment, patient recruitment strategies, and study close-out activities.

Conocimientos

Budget management

Vendor management

Cross-functional leadership

Project management

Trial management systems

ICH/GCP knowledge

Microsoft Office

Global clinical trials

Educación

Bachelor's degree

Herramientas

CTMS

TMF

IVRS/IWRS

EDC

MS Office (Project/PowerPoint/Word/Excel)

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to drive end-to-end delivery of clinical studies from a leading hub in the US. The role collaborates with cross-functional teams to ensure projects stay on schedule, within budget, and compliant with ICH/GCP guidelines.

Responsibilities include protocol input, site selection, investigator meetings, and oversight of CTMS/EDC/IVRS systems, with 25% travel. On-site locations include Armonk, NY; Warren, NJ; Cambridge, MA.