Associate Director, Risk Based Quality Management, Oncology
Core
Lead Risk Based Quality Management (RBQM) strategy and execution for Phase 1-4 oncology clinical trials, ensuring data quality and inspection readiness through centralized monitoring and cross-functional alignment.
Role type
Senior IC Associate Director, Risk Based Quality Management (Oncology)
Builds
High-quality clinical trial data and risk mitigation strategies for oncology investigational assets
Domain
Biopharmaceuticals / Clinical Research / Oncology
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
RBQM principles, centralized monitoring, RACT/QRMP development, KRIs/QTLs interpretation, targeted SDV/SDR, clinical data review, inspection readiness, risk analytics, stakeholder facilitation
Preferred skills
Advanced degree, enterprise-level RBQM initiatives, continuous improvement efforts
Technologies
Microsoft Office, clinical data systems, centralized monitoring tools, reporting platforms, data visualization tools
Responsibilities
Facilitate RBQM strategy adoption and training; Lead cross-functional risk assessment meetings; Own development of RACTs and QRMPs; Partner on KRI/QTL definition and monitoring; Lead centralized monitoring and signal detection; Provide expert guidance on targeted SDV/SDR; Manage direct reports
Seniority
Senior, hands-on IC with management responsibilities
