Oncology Clinical Study Lead - Global Trial Delivery

Regeneron Pharmaceuticals; New Jersey; Vor Ort; USD 129.000 - 210.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals seeks a Manager, Clinical Study Lead to oversee global execution of smaller/less complex trials from design to close-out. You will manage timelines, budgets, and quality per Regeneron SOPs and ICH/GCP, with oversight varying between internally sourced and CRO-led studies.

You will lead cross-functional study teams, contribute to protocol development, and manage study documentation, systems, and vendor engagement.

Qualifikationen

• Bachelor’s degree and ≥6 years of relevant industry experience.
• Extensive budget and vendor management expertise.
• Proficient with trial management systems and MS applications.
• Global clinical trial operations experience; knowledge of ICH/GCP.
• Strong project management and cross-functional leadership.

Aufgaben

• Lead cross-functional study team and oversee delivery within timelines, budget, and quality.
• Provide operational input to protocols; lead feasibility and site selection.
• Oversee study documentation and data management plans.
• Set up and maintain study systems (CTMS, TMF) and ensure registry compliance.
• Identify outsourcing needs; manage CROs and third-party vendors.
• Contribute to budget and timeline development; oversee scope changes.
• Lead risk assessment, patient recruitment, and data monitoring activities.
• Manage study close-out, budgets, TMF, and study drug accountability; contribute to study reports.
• Directly supervise CTM staff and drive process improvements; mentor team.

Kenntnisse

Budget management

Vendor management

Cross-functional leadership

Project management

MS Office proficiency

Ausbildung

Bachelor's degree

Tools

IVRS/IWRS

EDC

CTMS

TMF

PowerPoint

Excel

Jobbeschreibung

Regeneron Pharmaceuticals seeks a Manager, Clinical Study Lead to oversee global execution of smaller/less complex trials from design to close-out. You will manage timelines, budgets, and quality per Regeneron SOPs and ICH/GCP, with oversight varying between internally sourced and CRO-led studies.

You will lead cross-functional study teams, contribute to protocol development, and manage study documentation, systems, and vendor engagement.