Oncology Clinical Study Lead - Global Trials Manager

Regeneron Pharmaceuticals, Inc.; New Jersey; Vor Ort; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to drive global execution of smaller or less complex trials from design to close-out with oversight and SOP alignment.

You’ll lead cross-functional teams, manage timelines and budgets, engage CROs, contribute to protocol input, and ensure quality and regulatory compliance. Travel up to 25% may be required as part of coordinating sites and vendors across regions.

Qualifikationen

• Bachelor’s degree in Life Sciences or related field required.
• At least six years of relevant industry experience preferred.
• Extensive budget management and vendor management experience.
• Strong protocol, ICH/GCP knowledge and cross‑functional leadership.

Aufgaben

• Leads the cross‑functional study team responsible for clinical study delivery.
• Oversees timelines, deliverables, and budget; escalates issues as needed.
• Provides input into protocol development and feasibility assessments.
• Manages study documentation (CRFs, DMP, monitoring plans, etc.).
• Oversees CTMS, TMF setup and regulatory registry compliance.
• Engages CROs/vendors, contracts, and scope alignment; monitors performance.

Kenntnisse

Cross-functional leadership

Budget management

Project management

ICH/GCP knowledge

Vendor management

CTMS/EDC proficiency

Ausbildung

Bachelor’s degree in Life Sciences or related field

Tools

CTMS

TMF

EDC

IVRS/IWRS

Microsoft Office (PowerPoint, Word, Excel)

Jobbeschreibung

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Clinical Study Lead to drive global execution of smaller or less complex trials from design to close-out with oversight and SOP alignment.

You’ll lead cross-functional teams, manage timelines and budgets, engage CROs, contribute to protocol input, and ensure quality and regulatory compliance. Travel up to 25% may be required as part of coordinating sites and vendors across regions.