Global Oncology Clinical Study Lead

Regulatory Jobs; Armonk, Cambridge (NY, MA); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron is seeking a Manager, Clinical Study Lead to direct the global execution of clinical studies from design through close-out. You will manage timelines, budgets, and governance to ensure adherence to SOPs and ICH/GCP, with responsibility for internally sourced studies or CRO-led work.

You will lead cross-functional teams, oversee study documentation, vendor engagement, and risk management while driving continuous improvement of CTM SOPs and study processes.

Qualifications

• Bachelor’s degree and at least six years of relevant industry experience.
• Extensive budget management expertise and vendor oversight.
• Strong protocol input, data management and trial delivery experience.
• Knowledge of ICH/GCP and regulatory guidelines; proficient with trial systems.

Responsibilities

• Leads the cross-functional study team responsible for clinical study delivery and oversight.
• Manages timelines, deliverables and budget; raises issues and implements corrective actions.
• Provides operational input into protocol development and site selection.
• Oversees study documentation, CTMS, TMF, and data management plans.
• Manages vendor engagement, contracting, and CRO oversight; ensures scope alignment.
• Guides budget and timeline development with change control; monitors recruitment and retention.
• Leads risk assessment, mitigations, site activations, and monitoring oversight.
• Supervises CTM staff and participates in process improvements.

Skills

Budget management

Cross-functional leadership

Project management

Regulatory knowledge

ICH/GCP knowledge

Education

Bachelor’s degree

Tools

CTMS

TMF

EDC

IVRS/IWRS

Job description

Regeneron is seeking a Manager, Clinical Study Lead to direct the global execution of clinical studies from design through close-out. You will manage timelines, budgets, and governance to ensure adherence to SOPs and ICH/GCP, with responsibility for internally sourced studies or CRO-led work.

You will lead cross-functional teams, oversee study documentation, vendor engagement, and risk management while driving continuous improvement of CTM SOPs and study processes.