Global Study Manager - Haematology
Core
Deliver delegated aspects of global haematology clinical studies from protocol development through to CSR and archiving, ensuring compliance with ICH-GCP and global regulations.
Role type
Senior Global Study Manager (Clinical Operations)
Builds
Clinical trials for haematological malignancies (Phase I to registrational)
Domain
Biopharma / Haematology Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical research project management, Vendor management, ICH-GCP compliance, Study start-up execution, Cross-functional collaboration, Process improvement, Risk identification, Budget management, Regulatory inspection readiness, AI/automation tool application
Preferred skills
Phase III trial experience, Therapeutic area expertise in haematology
Technologies
AI tools, Automation platforms, Digital process optimization tools
Responsibilities
Coordinate global haematology studies from protocol development through to CSR and archiving, Ensure supply of Investigational product and study materials, Support GSADs in project management, Support the study team in the implementation of audits and regulatory inspections, Drive start-up activities and oversee early phase execution, Provide country and vendor oversight, Manage vendor contracts, budgets, and change orders, Oversee study documentation, Ensure inspection readiness through compliance to ICH-GCP and global regulations, Identify risks proactively and drive issue resolution across regions, Collaborate cross functionally with Clinical Operations, Regulatory, Data Management, Patient Safety, Supply Chain, and Procurement, Contribute to process improvements, innovation initiatives, and operational excellence
Seniority
Senior, hands-on IC
