Risk Management Lead

The Risk Management Lead (RML) serves as the subject matter expert for risk management and central monitoring in AbbVies 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.

Qualifications :

• Bachelors degree in life sciences risk-based or related discipline; advanced degree preferred.
• Minimum of 10 years 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.

This is a hybrid based role working onsite T-TH. Candidates must be local to Lake County IL; Irvine CA or Florham Park NJ and work onsite 3 days per week. 

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 
• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time