Director, Clinical Risk Management Post Approval Delivery Unit

Tasks

• Advise on regulatory compliance interpretation
• Coach risk monitoring and mitigation reviews
• Conduct quality risk assessments
• Coordinate quality integration during integration and acquisition
• Coordinate quality risk management
• Develop and guide quality agreement inputs
• Develop and support CAPA plans
• Develop risk mitigation plans
• Ensure trial data integrity
• Escalate serious quality issues
• Evaluate serious breaches for reporting
• Lead quality risk monitoring reviews
• Lead risk based trial oversight
• Maintain inspection readiness
• Prepare and maintain inspection documentation
• Provide remote investigational site inspection support
• Provide sponsor monitor inspection support
• Provide third party inspection support
• Support inspection narratives and site readiness
• Support patient rights safety and well being

Perks/Benefits

• N/A

Skills/Tech-stack

CAPA | Clinical Quality Plans | Clinical Trial Risk Management | Clinical quality | Clinical trial | Clinical trials | Data Visualization | Data analytics | GCP | ICH Guidelines | Inspection Readiness | Management System | Microsoft Office | Quality Management System | Quality Plans | Quality Risk Management | Quality management | Regulatory Compliance | Risk Assessment | Risk Management | S&OP