Manager, Clinical Risk Management

Tasks

• Advise on research quality and compliance
• Assess clinical quality risks
• Communicate risk updates
• Conduct risk-based clinical trial oversight
• Coordinate mock inspections
• Develop mitigation strategies
• Drive quality investigations consistency
• Escalate significant quality issues SQI
• Identify clinical quality risks
• Maintain clinical quality plans
• Maintain inspection readiness
• Monitor quality risks
• Perform CAPA effectiveness checks
• Prepare inspection narratives
• Provide post inspection support
• Provide quality issue guidance
• Review risk mitigation progress
• Support Corrective and Preventative Action CAPA
• Support investigator inspections
• Support site pre inspection visits
• Support sponsor monitor inspections
• Support third party inspections

Perks/Benefits

• Travel 10 percent

Skills/Tech-stack

CAPA | CAPA effectiveness checks | Clinical Quality Plans | Clinical quality | Clinical trials | Data Integrity | Data Science | Data Visualization | Data analytics | Digital Health | Effectiveness Checks | GCP | ICH Guidelines | Inspection Readiness | Microsoft Office | Quality Plans | Real-World Evidence | Regulatory Compliance | Risk-Based Monitoring | Risk-based | Spotfire | Tableau