Risk Management Lead
AbbVie
AbbVie seeks a Risk Management Lead to serve as subject matter expert for risk-based quality management across global clinical trials. The role involves leading strategic planning and implementation of risk mitigation practices, partnering with study teams to ensure regulatory compliance and high-quality trial execution.
Responsibilities
- Lead embedding and adoption of risk-based quality management model across clinical study teams
- Facilitate Risk Assessment and Mitigation Planning meetings and maintain RAMP documentation throughout study lifecycle
- Guide teams in identifying critical data/processes, defining Key Risk Indicators, and establishing control measures
- Analyze quality metrics and risk signals to drive continuous improvement and early intervention
- Support inspection readiness, audit response, and regulatory compliance activities
Requirements
- Bachelor's degree in life sciences or related discipline; advanced degree preferred
- Minimum 10 years clinical operations experience with proven risk management or RBQM expertise
- Strong knowledge of risk management methodologies and ICH/GCP regulatory standards
- Demonstrated ability to influence cross-functional teams and drive organizational change
- Proficiency with data analysis and visualization tools
- Experience leading in dynamic global environments with multi-jurisdictional studies
Vacancy posted 16 days ago
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