Global Study Associate Manager
Core
Oversees study delivery for clinical trials in partnership with enablement teams and external service providers, ensuring adherence to quality, time, and cost objectives.
Role type
Senior clinical study management (outsourced studies)
Builds
Clinical study delivery lifecycle
Domain
Pharmaceutical industry, clinical research
Required skills
Clinical study lifecycle management, CRO management, 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, knowledge of GXP (GMP/GLP)
Technologies
Trial Master File (TMF) systems, advanced computer tools
Responsibilities
Provide oversight to ensure study delivery meets objectives, prepare delegated study documents, facilitate interactions with internal functions and external CROs, manage Investigational product supply, support Global Study Leaders with budget and CRO management, identify risks and develop mitigation plans, ensure study documents are complete and verified for quality.
Seniority
Senior, hands-on IC