Global Study Manager - Cell Therapy
Core
Orchestrate complex, global clinical studies for next-generation cancer therapies (cell therapy) from protocol development through close-out and archiving.
Role type
Senior Global Study Manager (Clinical Operations)
Builds
Global clinical trials for oncology cell therapy products
Domain
Pharmaceutical industry / Oncology / Cell Therapy
Required skills
Clinical development process knowledge, ICH/GCP guidelines, external service provider management, project management, risk identification and mitigation, budget management, supply chain coordination
Preferred skills
Advanced degree, experience in all phases of clinical study lifecycle, GXP knowledge (GMP/GLP)
Technologies
Trial Master File systems, Clinical Study Agreement tools
Responsibilities
Provide oversight to ensure study delivery meets time, cost, and quality objectives; prepare delegated study documents (ICF, CSA); facilitate interactions with internal functions and external CROs; manage Investigational product supply; support budget management and invoice reconciliation; ensure inspection readiness of study documents; lead process improvement projects
Seniority
Senior, hands-on IC
