Senior Global Clinical Study Lead

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 multiple clinical trials from design through close-out, owning timelines and budgets while ensuring adherence to SOPs and ICH/GCP. This role involves leading CROs and internal teams to deliver high-quality study outcomes.

You will drive feasibility, site evaluation, and document oversight, while managing study systems and risk. On-site collaboration is expected in Armonk, NY and surrounding locations.

Formación

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management expertise and proven ability to build productive study teams and collaborations; demonstrated vendor management experience.
• Strong technical proficiency with trial management systems and Microsoft applications (Project, PowerPoint, Word, Excel) and platforms such as IVRS/IWRS and EDC.
• Experience in global clinical trial operations, ICH/GCP knowledge, regulatory guidelines, and strong project management and cross-functional leadership.

Responsabilidades

• Leads the cross-functional study team responsible for clinical study delivery and oversees execution against timelines, deliverables, and budget.
• Provides operational input into protocol development; leads feasibility assessments and site evaluation/selection; leads investigator meeting prep and execution.
• Oversees study documentation (CRFs, DMP, MP, etc.) and maintenance of study systems (CTMS, TMF); ensures regulatory compliance.
• Identifies outsourcing needs and leads vendor engagement, contracting, and management with CROs and third-party vendors.
• Drives risk assessment, patient recruitment strategies, and monitoring; manages close-out activities and contributes to clinical study reports.
• Assigns tasks to Clinical Study Management staff; supervises CTM staff and participates in process improvements and CTM SOP enhancements.

Conocimientos

Leadership

Program management

ICH/GCP knowledge

Cross-functional collaboration

Educación

Bachelor’s degree

Herramientas

Trial management systems

Microsoft applications (Project PowerPoint Word Excel)

IVRS/IWRS

EDC

Descripción del empleo

Regeneron is seeking a Manager, Clinical Study Lead to oversee the global execution of multiple clinical trials from design through close-out, owning timelines and budgets while ensuring adherence to SOPs and ICH/GCP. This role involves leading CROs and internal teams to deliver high-quality study outcomes.

You will drive feasibility, site evaluation, and document oversight, while managing study systems and risk. On-site collaboration is expected in Armonk, NY and surrounding locations.