Senior Specialist, Clinical Risk Management
GB006 High Wycombe, United Kingdom
GBP 55K-58K (estimate) Senior-level Full Time
Tasks
- Advise on quality and compliance questions
- Assess clinical protocol risks
- Collaborate with risk owners on mitigation effectiveness
- Communicate risk updates in governance forums
- Coordinate clinical trial quality risk identification
- Coordinate site preparation for inspection
- Develop and implement CAPA plans
- Develop risk mitigation strategies
- Escalate systemic quality risks
- Evaluate serious breaches for health authority reporting
- Maintain clinical quality plans
- Perform CAPA effectiveness checks
- Prepare for inspections and mock inspections
- Provide guidance for significant quality issues
- Provide post inspection support
- Review risk areas and mitigation progress
- Support investigator sponsor monitor inspections
- Support quality investigations
Perks/Benefits
Skills/Tech-stack
Audit management | CAPA | Clinical Quality Plans | Clinical Trial Risk Management | Clinical quality | Clinical trial | Clinical trials | Data Visualization | Data analytics | GCP | Health Authority Inspections | ICH Guidelines | Inspection Readiness | Management systems | Microsoft Office | Project Management | Quality Management Systems | Quality Plans | Quality investigations | Quality management | Regulatory Compliance | Risk Management | Spotfire | Tableau
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