Director, Clinical Risk Management Post Approval Delivery Unit
GB006 High Wycombe, United Kingdom
GBP 75K-90K (estimate) Executive-level Full Time
Tasks
- Communicate quality risks and mitigations
- Coordinate identification assessment mitigation quality risks
- Coordinate quality integration during acquisition integration
- Develop inspection narratives and documents records
- Develop risk mitigation plans
- Ensure patient rights safety well being
- Ensure trial data integrity
- Escalate quality issues
- Evaluate serious quality breaches
- Lead inspection processes and tools
- Lead risk based trial oversight activities
- Maintain inspection readiness
- Manage quality agreements input
- Manage risk monitoring reviews
- Oversee quality risk management
- Prepare sites of interest for inspection
- Provide guidance on quality investigations
- Provide independent compliance consultancy
- Provide sponsor monitor inspection support
- Support corrective and preventative action plans
Perks/Benefits
- N/A
Skills/Tech-stack
CAPA | Clinical Research | Clinical trials | Compliance Risk | Corrective Preventative Action | Data Visualization | Data analytics | GCP | ICH Guidelines | Inspection Readiness | Management systems | Microsoft Office | Preventative Action | Project Management | Qms | Quality Management Systems | Quality Risk Management | Quality management | Regulatory Compliance | Risk Assessment | Risk Management | Risk monitoring | S&OP | Tableau | Vendor management
Education
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