Senior Oncology Clinical Study Lead

Regeneron Pharmaceuticals; Cambridge (MA); Presencial; USD 129.000 - 210.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Study Lead to globally execute smaller or less complex trials, from design through closeout. You will own study timelines, budgets, and ensure SOP and ICH/GCP compliance.

The role involves coordinating CROs and internal teams to drive continuous process improvement. You will contribute to protocol inputs, site selection, investigator meetings, and study documentation, while supervising CTM staff and maintaining systems like CTMS and TMF.

Formación

• Bachelor’s degree and at least six years in the industry.
• Extensive budget management expertise with proven ability to lead study teams.
• Strong knowledge of ICH/GCP and regulatory guidelines; solid project management skills.

Responsabilidades

• Leads cross-functional study teams for clinical study delivery and oversees timelines, deliverables and budget.
• Provides input on protocol development and feasibility assessments for region selection.
• Oversees study documentation and ensures TMF, data management plans and SAP alignment.
• Manages setup and maintenance of study systems (CTMS, TMF) and regulatory compliance.
• Coordinates outsourcing needs and manages CRO/vendor engagements and budgets.
• Drives risk assessment, patient recruitment strategies, site monitoring, and data query resolution.

Conocimientos

Budget management

Vendor management

Trial management systems

Project leadership

Cross-functional collaboration

Operational optimization

Educación

Bachelor’s degree + 6+ years experience

Herramientas

IVRS/IWRS

EDC

Microsoft Office

Descripción del empleo

Regeneron Pharmaceuticals, Inc. seeks a Manager, Clinical Study Lead to globally execute smaller or less complex trials, from design through closeout. You will own study timelines, budgets, and ensure SOP and ICH/GCP compliance.

The role involves coordinating CROs and internal teams to drive continuous process improvement. You will contribute to protocol inputs, site selection, investigator meetings, and study documentation, while supervising CTM staff and maintaining systems like CTMS and TMF.