Risk Management Lead
Core
Subject matter expert for risk management and central monitoring in AbbVie's Risk-Based Quality Management (RBQM) model, leading strategic planning and implementation across global clinical trials.
Role type
Senior IC Risk Management Lead (Clinical Operations)
Builds
Risk mitigation strategies and RBQM process adoption for clinical study teams
Domain
Clinical trials, Life Sciences, Regulatory Compliance
Required skills
Risk management methodologies, RBQM model expertise, Clinical operations experience, ICH/GCP regulatory standards, Data analysis, Cross-functional leadership, Change management
Preferred skills
Advanced degree in life sciences or related discipline
Technologies
Data analysis/visualization tools
Responsibilities
Lead embedding and adoption of the end-to-end RBQM model within clinical study teams; Partner with cross-functional leads to develop and implement risk management strategies; Facilitate Risk Assessment and Mitigation Planning (RAMP) meetings; Guide teams in identifying critical data/processes and defining Key Risk Indicators (KRIs); Analyze quality metrics/data to drive continuous improvement; Monitor risk mitigation execution and track issue trends; Support inspection readiness and audit response.
Seniority
Senior, hands-on IC