Specialist I/Specialist II, Evidence Project Management, Oncology
Core
Operational delivery and oversight of AstraZeneca-sponsored evidence studies and early access programs (EAP) to ensure inspection readiness and quality.
Role type
Specialist, Evidence Project Management
Builds
Clinical study oversight deliverables, inspection-ready documentation, and program tracking systems
Domain
Life Sciences / Oncology / Clinical Research
Deliverable
dashboards & analysis
Required skills
Clinical study lifecycle knowledge, GCP/ICH guidelines, inspection readiness management, TMF/MF quality control, CRO collaboration, data management, budget support, stakeholder reporting
Preferred skills
Advanced degree in medical/biological sciences, administrative training, analytical skills
Technologies
VCV, SPOL, PharmaCM, TMF/MF systems
Responsibilities
Maintain Study Inspection Readiness Tool, coordinate periodic TMF/MF QC, customize Expected Document Lists, support study start-up activities, manage internal study trackers and systems, support budget management (POs, invoicing), track EAP program participation and status, ensure documentation of oversight tasks
Seniority
Specialist, operational execution
