Manager, RBQM
Core
Execute and continuously improve risk-based quality management (RBQM) approaches in clinical trials to ensure patient safety, data integrity, and compliance.
Role type
Manager, Risk-Based Quality Management (RBQM)
Builds
Clinical trial quality management processes and risk mitigation strategies
Domain
Biopharma / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Risk assessment, Centralized monitoring, Quality Tolerance Limits (QTLs), Key Risk Indicators (KRIs), Integrated Quality Risk Management Plan (IQRMP), Clinical systems (CTMS, EDC, monitoring platforms), GCP/ICH E6(R2)/R3 regulatory knowledge, Data quality checks, Trend analysis, Corrective and preventive actions (CAPA)
Preferred skills
Life sciences or healthcare degree
Responsibilities
Support study- and program-level risk assessments and mitigation tracking; Configure and validate KRIs and QTLs in monitoring systems; Perform data quality checks and support User Acceptance Testing (UAT); Collaborate on monitoring oversight activities and review CRO/site reports; Maintain documentation for inspection readiness and audit preparation; Contribute to training initiatives and process improvement efforts.
Seniority
Manager, hands-on IC