Senior Specialist, Clinical Risk Management
US054 PA Horsham - 200 Tournament Dr, United States
USD 94K-151K Senior-level Full Time
Tasks
- Advise on research quality and compliance
- Assess quality risks
- Communicate risk updates to stakeholders
- Conduct effectiveness checks
- Coordinate mock inspections
- Coordinate risk based trial oversight
- Develop and implement corrective and preventative action plans
- Escalate serious quality issues
- Evaluate mitigation actions effectiveness
- Evaluate serious breaches for health authority reporting
- Identify clinical protocol risks
- Maintain clinical quality plans in quality repository
- Mitigate quality risks for trial data integrity
- Prepare sites for inspection
- Provide post inspection support
- Support inspection readiness activities
- Support investigator sponsor monitor inspections
- Support quality investigations guidance
Perks/Benefits
- N/A
Skills/Tech-stack
Audit management | Clinical Practice | Clinical risk management | Clinical trials | Compliance Management | Corrective and Preventive Actions | Data Analysis | Data Visualization | Good Clinical Practice | ICH Guidelines | Inspection Readiness | Management systems | Microsoft Office | Preventive actions | Project Management | Quality Management Systems | Quality management | Regulatory Compliance | Risk Management | Spotfire | Tableau
Education
Regions
Countries
States
Cities
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