Global Study Manager - Late Development Oncology
Core
Orchestrate complex, global oncology studies to accelerate lifesaving medicines from protocol to meaningful results, ensuring inspection-ready performance and delivery to time, cost, and quality.
Role type
Senior Global Study Manager (Late Development Oncology)
Builds
Pivotal oncology trials and global clinical programs
Domain
Pharmaceutical industry / Oncology / Clinical Development
Deliverable
client delivery
Required skills
Study delivery leadership, cross-functional orchestration, document ownership, meeting planning and facilitation, supply readiness, risk and issue management, inspection readiness and quality assurance, budget and vendor oversight, global coordination
Preferred skills
Advanced degree in relevant field, formal project management certification (PMP/PRINCE2), experience delivering global multicountry oncology studies in late-stage development, oversight of CROs and external service providers, familiarity with TMF/eTMF systems, clinical supply planning, EDC and data management interfaces, budget tracking and financial governance, fluency in additional languages
Technologies
TMF/eTMF systems, EDC, clinical supply chain platforms
Responsibilities
Provide oversight of delegated aspects of study execution from protocol development through close-out; maintain and facilitate interactions with internal functions and external providers (including CROs); lead preparation of delegated study documents and external provider materials; plan and conduct internal and external meetings; ensure timely supply of investigational product; proactively identify risks and issues and drive resolution; ensure study documents are complete and verified for inspection readiness; support budget management and CRO oversight; support Global Study Directors in project management; operate across multiple countries balancing local requirements with global standards
Seniority
Senior, hands-on IC with leadership responsibilities
