Associate Director, Clinical Risk Management
GB006 High Wycombe, United Kingdom
GBP 50K-60K (estimate) Mid-level Full Time
Tasks
- Assess clinical trial quality risks
- Coach peers and train new employees
- Communicate risk updates in governance forums
- Coordinate clinical trial quality risk identification
- Coordinate mock inspections
- Develop inspection narratives and prepare sites
- Develop quality investigation interpretation
- Ensure compliance with regulatory requirements
- Execute risk based trial oversight
- Lead risk review meetings
- Maintain clinical quality plans
- Mitigate quality risks for patient safety and rights
- Perform quality risk monitoring reviews
- Provide CAPA planning guidance
- Provide inspection post support
- Support inspection readiness activities
- Support investigator sponsor monitor and third party inspections
Perks/Benefits
- N/A
Skills/Tech-stack
CAPA | Clinical Quality Plans | Clinical quality | Clinical trials | Data Visualization | Data analytics | EMA | FDA | GCP | GLP | GMP | ICH Guidelines | Inspection Readiness | Microsoft Office | Pharmacovigilance | Project Management | Quality Plans | Quality Risk Monitoring | Regulatory Compliance | Risk Management | Risk monitoring | Spotfire | Tableau
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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