Global Study Associate Manager
Core
Oversees clinical study delivery in partnership with enablement teams and external providers, ensuring adherence to quality, time, and cost objectives.
Role type
Senior clinical study management (outsourced studies)
Builds
Clinical studies for pharmaceutical products
Domain
Pharmaceutical industry, clinical research
Deliverable
client delivery
Required skills
Clinical study lifecycle management, CRO oversight, risk identification and mitigation, budget management, project management, ICH/GCP guidelines knowledge, document preparation and verification
Preferred skills
Medical or biological sciences background, experience in drug development phases, GXP knowledge (GMP/GLP), process improvement leadership
Technologies
Trial Master File systems, advanced computer tools for day-to-day tasks
Responsibilities
Provide oversight to ensure study delivery meets objectives; prepare delegated study documents and external service provider specifications; facilitate interactions with internal functions and external CROs; manage Investigational product supply; identify risks and develop mitigation plans; verify study document quality in Trial Master File; support Global Study Leaders with budget management and CRO management; lead process improvement projects
Seniority
Senior, hands-on IC with delegation support
