Global Study Manager
Core
Lead delegated aspects of global haematology clinical studies from protocol to publication, ensuring timelines, quality, and budget are met across countries and vendors.
Role type
Senior Global Study Manager (Clinical Development)
Builds
Global clinical studies for haematology pipeline
Domain
Clinical Research / Haematology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, Vendor and CRO oversight, Regulatory compliance (ICH-GCP), Budget and contract management, Cross-functional team leadership, Inspection readiness, Study lifecycle management
Preferred skills
Haematology or Oncology therapeutic area experience, GXP knowledge (GMP/GLP), Vendor management (IRT, labs), PhD or MSc
Technologies
None stated
Responsibilities
Develop study documents and amendments, manage vendor setup and change orders, partner with CROs for delivery, conduct investigator and monitor meetings, support audits and regulatory inspections, manage study budgets and invoices, lead process improvement initiatives
Seniority
Senior, hands-on IC
