Associate Director, Clinical Risk Management
ES022 Janssen Madrid, Spain
EUR 60K-106K (estimate) Mid-level Full Time
Tasks
- Advise on research quality compliance
- Coach others on risk monitoring and mitigation
- Coordinate mock inspections
- Develop and implement CAPA plans
- Develop inspection narratives
- Drive quality risk monitoring reviews
- Escalate significant quality issues to management
- Facilitate risk updates in governance working groups
- Highlight systemic risk to management
- Identify assess mitigate clinical quality risks
- Interpret issues requiring quality investigations
- Lead risk reviews with risk owners
- Maintain clinical quality plans
- Manage inspection readiness activities
- Participate in clinical risk management working groups
- Perform effectiveness checks for CAPA
- Prepare sites for health authority inspection
- Provide guidance on significant quality issues
- Provide post inspection support
- Support investigator sponsor monitor third party inspections
- Train and coach peers and new employees
Perks/Benefits
- Bereavement leave
- Caregiver leave
- Parental leave
- Service anniversary awards
- Vacation days
- Volunteer leave
- Well-being reimbursement
Skills/Tech-stack
CAPA | Clinical Data Integrity | Clinical Quality Plans | Clinical data | Clinical quality | Clinical trials | Corrective and Preventive Action | Data Integrity | Data Visualization | Data analytics | EMA | FDA | GCP | GLP | GMP | Good Pharmacovigilance Practice | ICH Guidelines | Inspection Readiness | Microsoft Office | Patient safety | Preventive Action | Project Management | Quality Plans | Regulatory Compliance | Risk Management | Spotfire | Tableau
Education
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