Senior Specialist, Clinical Risk Management

Tasks

• Assess clinical protocol setup risks
• Communicate risk updates through governance
• Coordinate clinical trial quality risk identification
• Coordinate mock inspections
• Develop corrective and preventative action plans
• Ensure availability of key documents and records
• Escalate significant quality issues to management
• Evaluate mitigation actions effectiveness
• Evaluate serious breaches for health authority reporting
• Implement risk mitigation strategies
• Interpret quality issues for investigations
• Maintain clinical quality plans in quality repository
• Perform effectiveness checks CAPA
• Prepare sites for inspection
• Provide guidance for significant quality issues
• Provide research quality compliance guidance
• Review risk areas with risk owners
• Support inspection readiness with trial teams
• Support investigator sponsor monitor and third party inspections

Perks/Benefits

• Annual bonus
• Bereavement leave
• Caregiver leave
• Insurance plans
• Parental leave
• Recognition awards
• Service anniversary awards
• Vacation days
• Volunteer leave
• Well-being reimbursement

Skills/Tech-stack

Audit management | CAPA | Clinical Quality Plans | Clinical Trial Risk Management | Clinical quality | Clinical trial | Clinical trials | Data Science | Data Visualization | Data analytics | Digital Health | GCP | ICH Guidelines | Inspection Readiness | Management System | Microsoft Office | Quality Management System | Quality Plans | Quality Risk Management | Quality Standards | Quality management | Regulatory Compliance | Risk Management | Spotfire | Tableau