Strategic Risk & RBQM Lead for Clinical Trials

ABBVIE; Irvine (CA); Hybrid; USD 125,000 - 237,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Long-term incentive programs

Paid time off

Job summary

AbbVie in Irvine, CA is seeking a Risk Management Lead to advance RBQM in global clinical trials. You will partner with study teams to embed risk practices, define KRIs, and drive mitigation across programs.

The role requires a decade of clinical operations experience in risk management, strong analytical skills, and a proven ability to influence cross-functional teams in a highly regulated environment.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree preferred.
• Minimum 10 years’ experience in clinical operations with risk management expertise.
• Strong knowledge of risk management methodologies and regulatory standards.

Responsibilities

• Lead embedding of the RBQM model across clinical study teams.
• Partner with cross-functional leads to develop risk management strategies.
• Facilitate RAMP meetings and maintain RAMP documentation.
• Identify KRIs, define risk controls, and establish response plans.
• Ensure alignment with study plans and global monitoring strategies.
• Coach teams on risk mindset and process maturity.
• Analyze quality metrics and risk signals to drive improvement.
• Monitor risk mitigation, track trends, and document issues.
• Support inspection readiness and regulatory compliance.
• Contribute to RBQM process optimization and knowledge sharing.

Skills

Risk management

RBQM

Quality management

Regulatory compliance

ICH/GCP

Cross-functional influence

Education

Bachelor's in life sciences

Advanced degree preferred

Tools

Data analysis tools

Visualization software

Job description

AbbVie in Irvine, CA is seeking a Risk Management Lead to advance RBQM in global clinical trials. You will partner with study teams to embed risk practices, define KRIs, and drive mitigation across programs.

The role requires a decade of clinical operations experience in risk management, strong analytical skills, and a proven ability to influence cross-functional teams in a highly regulated environment.