Study Risk Lead - Remote

Overview

The Study Risk Lead is the risk management subject matter expert for study execution and central monitoring in AbbVie’s end-to-end RBQM model—a critical pillar required in AbbVie’s mission to be a world-class R&D organization.

In Short

• Coach and develop the risk mindset within the study team.
• Support the development of business processes for risk mitigation.
• Collaborate with the study team for quality pursuits.
• Facilitate Risk Assessment and Mitigation meetings.
• Prepare Risk Assessments and Mitigation Plans as per AbbVie standards.
• Review and evolve Risk Assessments throughout the study.
• Identify critical data and processes for study success.
• Define Key Risk Indicators for effective risk management.
• Communicate findings to ensure understanding across stakeholders.
• Support the execution of RBM processes across the R&D portfolio.

Requirements

• Bachelor’s degree.
• Minimum of 5 years of clinically related experience.
• Experience in an RBQM-framework model.
• 1+ years of clinical research monitoring experience preferred.
• Risk Management Certifications (e.g., CRM, PRM) are a plus.
• Familiarity with therapeutic indications and clinical trial regulations.
• Ability to analyze complex business/technical situations.
• Willingness to learn about risk management in clinical trials.

Benefits

• Comprehensive benefits package including paid time off.
• Medical/dental/vision insurance.
• 401(k) participation for eligible employees.
• Eligibility for short-term and long-term incentive programs.