Global Study Manager - FSP - UK - PACT/MAP experience
Core
Fully client-embedded role accountable for delivering clinical operation activities of studies until archiving, generating robust delivery plans, and ensuring time, quality, and budget adherence.
Role type
Senior Global Study Manager (Clinical Operations)
Builds
Clinical studies for a leading bio-pharma company
Domain
Life Sciences / Clinical Research / Bio-pharma
Required skills
Global study management (PACT/MAP), End-to-end study delivery, Clinical protocol development, Vendor management (CRO), Budget management, Risk mitigation, Stakeholder communication, Cross-functional leadership, Regulatory compliance (ICH/GCP), Data management, Safety management
Preferred skills
Experience in Phase II/III trials, Competent authority inspections (FDA/EMA/MHRA), China/Japan/Africa market exposure, PI/PIV trial experience
Technologies
eTMF, Clinical systems, Project management tools
Responsibilities
Lead study team to achieve deliverables, Conduct Study Initiation Meetings and Investigator meetings, Oversee vendor setup and management, Track recruitment and budget, Mitigate study risks, Ensure protocol compliance and inspection readiness, Operate within study budget, Lead quality efforts for continual inspection readiness.
Seniority
Senior, hands-on IC