Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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.
- 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.
Qualifications
- Bachelor’s degree in life sciences, risk-based, or related discipline; advanced degree preferred.
- Extensive comprehensive experience in clinical operations, with proven expertise in risk management, RBQM, or quality management.
- Excellent working knowledge of risk management methodologies (including risk identification, assessment, mitigation, and documentation).
- Demonstrated ability to influence cross-functional teams, senior management, and drive change management initiatives.
- Deep understanding of ICH/GCP, regulatory standards, and clinical trial processes.
- Strong analytical, critical thinking, and problem-solving skills; proficiency with data analysis/visualization tools.
- Exceptional communication, documentation, and interpersonal skills.
- Proven ability to lead in a dynamic global environment with complex, multi-jurisdictional studies.
- Mandatory hybrid model: 3 days onsite (Marlow)
Key Stakeholders: Clinical Site Management (CSM), Clinical Study Leadership (CSL), Strategic Clinical Operations, Therapeutic Area Medical Directors, Data Science, Compliance, Clinical Process Compliance, Quality Assurance, Vendor Management, and other cross-functional partners.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html