Global Clinical Study Lead Manager

Regeneron Pharmaceuticals, Inc.; New York (NY); Presencial; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Study Lead to drive global execution of smaller or less complex trials, from design through closeout, ensuring timelines, budgets, and SOPs are met.

This role leads cross-functional teams, oversees protocol input, site evaluation, vendor management, and study documentation, while advancing process improvements and adherence to ICH/GCP.

Formación

• Bachelor's degree and at least six years of relevant industry experience.
• Extensive budget and vendor management experience in clinical trials.
• Strong protocol input, site evaluation, and investigator meeting capabilities.
• Proven ability to lead cross-functional teams and manage study documents.
• Solid knowledge of ICH/GCP and regulatory guidelines; proficient in trial systems.

Responsabilidades

• Leads the cross-functional study team responsible for clinical study delivery, overseeing timelines, deliverables, and budget.
• Provides operational input into protocol development and feasibility for region/country selection.
• Oversees study documentation, data management, monitoring plans, and training plans.
• Manages setup/maintenance of study systems (CTMS, TMF) and regulatory compliance.
• Identifies outsourcing needs, engages CROs, and manages vendor contracts.
• Leads study-level risk assessment, patient recruitment strategies, and site activations.
• Oversees study close-out, data reconciliation, and contributes to study reports.
• Directly supervises CTM staff and drives process improvements across CTM SOPs.

Conocimientos

Cross-functional leadership

Study management

Budget management

Vendor management

CTMS / TMF knowledge

ICH/GCP knowledge

Educación

Bachelor's degree

Herramientas

CTMS

TMF

EDC

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Study Lead to drive global execution of smaller or less complex trials, from design through closeout, ensuring timelines, budgets, and SOPs are met.

This role leads cross-functional teams, oversees protocol input, site evaluation, vendor management, and study documentation, while advancing process improvements and adherence to ICH/GCP.