Global Study Manager CVRM
Core
Oversees clinical study delivery from protocol development through close-out and archiving, ensuring time, cost, and quality objectives are met.
Role type
Senior IC Global Study Manager
Builds
Clinical studies for BioPharmaceuticals
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
client delivery
Required skills
Clinical study lifecycle management, ICH/GCP guidelines, external service provider (CRO) oversight, risk identification and mitigation, project management, budget management, document quality verification
Preferred skills
Advanced degree, experience in all clinical study phases, GXP knowledge (GMP/GLP)
Technologies
Trial Master File systems
Responsibilities
Provide oversight to ensure study delivery; prepare delegated study documents; facilitate interactions with internal functions and external service providers; plan and conduct internal and external meetings; ensure supply of Investigational product; identify risks and develop mitigation plans; verify study document quality; support budget management; manage CRO Project Managers for outsourced studies; lead process improvement projects
Seniority
Senior, hands-on IC
