Senior RBQM Risk Management Lead

AbbVie; United States; Hybrid; USD 140,000 - 210,000; Full time

Job summary

AbbVie seeks a Risk Management Lead to drive RBQM across global clinical trials, partnering with study teams to embed risk-management practices and continuous improvement. You will guide KRIs, risk controls, and documentation, ensuring training and change management across functions to uphold quality and compliance.

The role requires 10+ years in clinical operations with risk management expertise, ICH/GCP knowledge, and strong analytical and communication skills.

Qualifications

• Bachelor’s 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.

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 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.

Skills

RBQM

Risk management

Clinical operations

Cross-functional

Data analysis

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

AbbVie seeks a Risk Management Lead to drive RBQM across global clinical trials, partnering with study teams to embed risk-management practices and continuous improvement. You will guide KRIs, risk controls, and documentation, ensuring training and change management across functions to uphold quality and compliance.

The role requires 10+ years in clinical operations with risk management expertise, ICH/GCP knowledge, and strong analytical and communication skills.