The Risk Management Lead (RML) serves as the subject matter expert for risk management and central monitoring in AbbVie’s Risk-Based Quality Management (RBQM) model. The RML leads the strategic planning, implementation, and continuous improvement of risk management practices across global clinical trials, partnering closely with study teams and Central Monitoring colleagues to cultivate a proactive and sustainable risk-mitigation culture in support of high-quality study execution and regulatory compliance.
Key Responsibilities:
- Lead embedding and adoption of the end-to-end RBQM model within and across clinical study teams.
- Partner with cross-functional leads to develop and implement risk management strategies across therapeutic areas/programs.
- Facilitate Risk Assessment and Mitigation Planning (RAMP) meetings; prepare, review, and update RAMP documentation throughout the study lifecycle.
- Guide cross-functional teams in identifying critical data/processes, defining relevant Key Risk Indicators (KRIs), and establishing effective risk controls and response plans.
- Ensure alignment of risk discussions with study plans and global monitoring strategies.
- Coach and influence teams in risk mindset, methodology, and process maturity while fostering organizational capabilities.
- Analyze quality metrics/data and risk signals across study, regional, and site levels to drive continuous improvement and early intervention.
- Monitor risk mitigation execution, track issue trends, and ensure proper documentation, escalation, and communication of risks/issues.
- Support inspection readiness, audit response, and regulatory compliance, in collaboration with Clinical Process Compliance and Quality Assurance.
- Lead and contribute to RBQM process optimization, knowledge sharing, and best practice dissemination across studies and therapeutic areas.