Director, Clinical Risk Management Post Approval Delivery Unit

Tasks

• Advise on quality agreements for partners
• Conduct effectiveness checks
• Coordinate quality integration for acquisitions
• Coordinate risk identification assessment mitigation
• Develop corrective preventive action CAPA plans
• Ensure trial data integrity patient safety and rights
• Escalate significant quality issues
• Evaluate serious breaches for reporting
• Lead quality investigations interpretations
• Lead quality risk monitoring reviews and coaching
• Lead risk based trial oversight
• Maintain inspection readiness with mock inspections
• Maintain quality management governance communication
• Oversee clinical quality risk management
• Prepare inspection narratives and site of interest documentation
• Provide inspection front and back room support
• Support remote investigational site inspections
• Support sponsor monitor inspections

Perks/Benefits

• Inclusive work environment
• Travel allowance up to 10 percent

Skills/Tech-stack

CAPA | Clinical Protocol | Clinical trials | Compliance Risk | Data Visualization | Data analytics | GCP | GLP | GMP | Good Pharmacovigilance Practice | ICH Guidelines | Inspection Readiness | Inspection Support | Management systems | Microsoft Office | Project Management | Quality Assurance | Quality Management Systems | Quality management | Regulatory Compliance | Risk Assessment | Risk Mitigation | S&OP | Spotfire | Tableau