Director, Clinical Risk Management Post Approval Delivery Unit

Tasks

• Approve clinical quality plans risk monitoring information
• Coach risk monitoring and mitigation reviews
• Communicate risk updates through governance forums
• Coordinate identification assessment mitigation of quality risks
• Coordinate quality integration for acquisitions where assigned
• Develop CAPA plans and effectiveness checks
• Develop and support quality agreements
• Develop inspection narratives and manage key documents
• Drive quality risk monitoring reviews
• Ensure compliance with regulatory requirements
• Escalate significant quality issues
• Lead inspection processes and inspection tools
• Lead quality risk assessment process
• Maintain inspection readiness
• Oversee clinical quality risk management
• Prepare sites for inspection
• Provide guidance on quality investigations
• Provide research quality compliance consultancy
• Provide sponsor monitor inspection support
• Provide strategic guidance on quality risk assessments
• Provide third party inspection support
• Support investigational site inspections

Perks/Benefits

• N/A

Skills/Tech-stack

CAPA | Clinical Protocol | Clinical Quality Plans | Clinical quality | Clinical risk management | Clinical trials | Data Integrity | Data Visualization | Data analytics | EMA | FDA | GCP | GLP | GMP | Good Pharmacovigilance Practice | Health Authority Inspections | ICH Guidelines | Inspection Readiness | Management systems | Microsoft Office | Patient safety | Project Management | Quality Management Systems | Quality Plans | Quality governance | Quality management | Regulatory Compliance | Risk Assessment | Risk Management | Risk monitoring | S&OP | Spotfire | Tableau