This role serves as the primary point of contact for quality and compliance matters to support high-quality clinical trial delivery within SMM Oncology Country teams
Job Summary
This role serves as the primary point of contact for quality and compliance matters to support high-quality clinical trial delivery within SMM Oncology Country teams.
The incumbent is responsible for drafting local country quality plans, managing annual quality control activities, and ensuring adherence to GCPs and LDO Clinical Operations objectives.
Key responsibilities include facilitating compliance issue resolution, conducting quality site visits, and acting as a subject matter expert during sponsor and investigator site inspections.
Matching Summary
This role serves as the primary point of contact for quality and compliance matters to support high-quality clinical trial delivery within SMM Oncology Country teams.
Skills & Requirements
Must-have
GCP compliance knowledge
Oncology clinical trial experience
Risk-based decision making
Veeva Quality Vault usage
CAPA management expertise
Nice-to-have
Cross-functional collaboration skills
Audit coordination experience
Global team interaction ability
Strategic quality planning
Advanced degree in life sciences
Key Requirements
Undergraduate degree in life sciences
Experience in GxP regulated pharmaceutical environment