Director, Clinical Risk Management Post Approval Delivery Unit

Tasks

• Coach risk monitoring and mitigation reviews
• Conduct serious breach evaluation
• Coordinate identification assessment mitigation of quality risks
• Coordinate mock inspections
• Coordinate quality integration for acquisition and integration
• Develop consistent interpretation of quality issues
• Develop quality agreements input
• Develop quality risk mitigation plans
• Ensure data integrity risk assessments
• Escalate serious quality issues
• Guide CAPA plans and effectiveness checks
• Lead risk monitoring reviews
• Maintain compliance with regulatory requirements and internal procedures
• Oversee clinical risk management
• Prepare sites of interest for inspection
• Provide independent advice on research quality and compliance
• Provide issue consultation and compliance assessment
• Provide sponsor monitor inspection support
• Support inspection readiness and inspection narratives
• Support third party inspection readiness

Perks/Benefits

• N/A

Skills/Tech-stack

CAPA | Clinical Practice | Clinical Quality Plans | Clinical Research | Clinical Trial Risk Management | Clinical quality | Clinical research regulations | Clinical trial | Clinical trials | Compliance Risk | Data Integrity | Data Visualization | GCP | GLP | GMP | GPvP | Good Clinical Practice | Good Laboratory Practice | Good Manufacturing Practice | Good Pharmacovigilance Practice | ICH Guidelines | Inspection Readiness | Laboratory practice | Management systems | Microsoft Office | Qms | Quality Management Systems | Quality Plans | Quality management | Research regulations | Risk Assessments | Risk Management | Risk monitoring | S&OP | Spotfire | Standard Operating Procedure | Tableau