Global Study Manager - FSP - UK - PACT/MAP experience
Core
End-to-end operational delivery of global clinical studies from initiation to archiving, ensuring robust plans and quality delivery for a leading bio-pharma company.
Role type
Senior Global Study Manager (Clinical Operations)
Builds
Clinical study deliverables including Study Initiation Meetings, Delivery Plans, TMF Quality Strategies, and DCT setups
Domain
Bio-pharma / Clinical Research / Global Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global study management, PACT/MAP experience, Clinical trial phases II-III, Cross-functional leadership, Clinical budget management, Vendor/CRO management, Risk mitigation, Protocol compliance, Stakeholder communication
Preferred skills
Experience in China/Japan/Africa markets, PI/PIV trial experience, Competent authority inspection exposure (FDA/EMA/MHRA)
Technologies
eTMF, Clinical systems, Project management tools
Responsibilities
Generate accelerated delivery plans meeting upper quartile performance targets, Lead study teams to achieve overall deliverables, Oversee activities across participating countries, Mitigate study risks proactively, Ensure protocol compliance and inspection readiness, Manage study budget and vendor relationships
Seniority
Senior, hands-on IC
