Global Clinical Study Lead & Delivery Manager

Regulatory Jobs; New York (NY); Presencial; USD 129.000 - 210.000; Jornada completa

Descripción de la vacante

Regeneron is seeking a Manager, Clinical Study Lead to oversee the global execution of smaller to mid-size clinical trials. You will drive timelines, budgets, and conduct in accordance with SOPs and ICH/GCP, coordinating with CROs and internal teams to ensure quality and compliance across studies.

You will guide protocol development, site selection, investigator meetings, and the creation of key study documents, while managing vendors and trial systems to support successful study close-out and

Formación

• Bachelor’s degree required with at least six years of relevant industry experience.
• Experience managing budgets and leading study teams.
• Strong knowledge of ICH/GCP and regulatory guidelines.
• Proficiency with trial management systems and related data tools.
• Ability to oversee vendor engagement and external study partners.

Responsabilidades

• Leads cross-functional study teams delivering clinical study execution to plan, timelines, and budgets.
• Provides operational input into protocol development and feasibility assessments across regions.
• Oversees study documentation and data management plans, monitoring, and data review activities.
• Manages set-up and maintenance of study systems (CTMS, TMF) ensuring regulatory compliance.
• Oversees outsourcing, vendor engagement, contracting and performance against scope of work.
• Monitors risk, recruitment, site activation, data entry, and deviations; drives corrective actions.

Conocimientos

Budget management

Vendor management

Cross-functional leadership

Trial management systems

Microsoft Project/Office

Educación

Bachelor’s degree

Herramientas

CTMS

TMF

IVRS/IWRS

EDC

MS Office (PowerPoint/Word/Excel)

Descripción del empleo

Regeneron is seeking a Manager, Clinical Study Lead to oversee the global execution of smaller to mid-size clinical trials. You will drive timelines, budgets, and conduct in accordance with SOPs and ICH/GCP, coordinating with CROs and internal teams to ensure quality and compliance across studies.

You will guide protocol development, site selection, investigator meetings, and the creation of key study documents, while managing vendors and trial systems to support successful study close-out and