Senior Clinical Study Lead — Global Trials & Delivery

Regeneron Pharmaceuticals; Armonk (NY); Vor Ort; USD 151.000 - 246.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals in Armonk, NY, is seeking a Senior Clinical Study Lead to drive global execution of large complex trials within Inflammation & Immunology. You will lead cross-functional teams, ensure ICH/GCP compliance, and manage study timelines and budgets.

The role requires a Bachelor's degree and 8+ years of trial experience, strong leadership, and advanced trial management system skills. On-site with hybrid flexibility; travel up to 25%.

Qualifikationen

• Bachelor's degree required; 8+ years in clinical trials.
• Strong leadership, interpersonal and negotiation skills.
• Proactive, self-disciplined with ability to meet deadlines.

Aufgaben

• Leads cross-functional study teams delivering global trials.
• Oversees study documentation: CRFs, data management plan, SAP, etc.
• Sets up/maintains CTMS and TMF systems.
• Manages outsourcing, vendors, budgets, and timelines.
• Leads risk assessment and mitigation at the study level.
• Oversees site activation, monitoring, recruitment, and data queries.
• Supervises CTM staff, performance management and development.
• Coordinates study close-out activities and database lock.

Kenntnisse

Cross-functional leadership

Trial management

Budget management

Timeline management

Stakeholder communication

Risk assessment

Ausbildung

Bachelor's degree

Tools

MS Office Suite

IVRS/IWRS

EDC

Jobbeschreibung

Regeneron Pharmaceuticals in Armonk, NY, is seeking a Senior Clinical Study Lead to drive global execution of large complex trials within Inflammation & Immunology. You will lead cross-functional teams, ensure ICH/GCP compliance, and manage study timelines and budgets.

The role requires a Bachelor's degree and 8+ years of trial experience, strong leadership, and advanced trial management system skills. On-site with hybrid flexibility; travel up to 25%.