Manager, Clinical Risk Management
US026 PA Spring House - 1400 McKean Rd, United States
USD 102K-177K Mid-level Full Time
Tasks
- Advise clinical teams on research quality and compliance
- Advise development and implementation of CAPA plans and effectiveness checks
- Communicate risk updates through quality working groups
- Coordinate identification assessment and mitigation of quality risks for clinical trials
- Develop consistent interpretation of issues requiring quality investigations
- Drive quality risk monitoring reviews and coach teams
- Lead inspection readiness activities and prepare sites for inspection
- Lead review of risk areas and risk mitigation progress
- Maintain clinical quality plans in quality repository
- Provide guidance on significant quality issues and manage escalations
- Provide support for investigator sponsor monitor and third party inspections
Perks/Benefits
- N/A
Skills/Tech-stack
CAPA | Clinical Quality Plans | Clinical quality | Clinical trials | GCP | GLP | GMP | GPvP | Good Laboratory Practice | Good Manufacturing Practice | Good Pharmacovigilance Practice | ICH Guidelines | Inspection Readiness | Laboratory practice | Management systems | Microsoft Office | Qms | Quality Management Systems | Quality Plans | Quality management | Regulatory Compliance | Risk Management
Education
Bachelor of Engineering | Bachelor of Medicine | Bachelor of Science
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