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. The Study Risk Lead partners with the cross functional study team
and the Central Monitor team.

The purpose of the Study Risk Lead is to establish the early detection and intervention framework
for study risks, determining what to look for and how to intervene effectively, to enable proactive
risk mitigation before the study starts and throughout the study as new risks emerge. The Study
Risk Leads function is de-centralized and includes team members from across the globe. Study Risk
Leads are responsible for multiple-jurisdiction studies with sites across the globe.

Responsibilities:

• Coach and develop the risk mindset, the discipline of risk management and risk practices/processes within the cross-functional study team—further maturing processes and building organizational capabilities in the pursuit of better quality and outcomes for patients, investigators, the study team and AbbVie as a business, and inspection readiness.
• Support and contribute to the development, embedding, growth and health of the necessary business process to support risk mitigation and global monitoring processes that align with the risks of programs and protocols.
• Work collaboratively in the pursuit of quality with the study team and cross-functional departments.
• Facilitate the Risk Assessment and Mitigation (RAMP) meetings (initial and ongoing).
• Support the cross-functional study team in identifying risks and planning for potential mitigations.
• Prepare Risk Assessments and Mitigation Plans (RAMP) documents as per AbbVie standards.
• Continually review and evolve the Risk Assessments and Mitigation Plans (RAMP) throughout the study to ensure proactive action and responses to anticipated risks as well as newly emerging real-time risks.
• Ensure the output of the RAMP discussions are reflected in applicable study plans so that team is focusing on the most important risks and mitigations.
• Guide the team in identifying the most critical data and processes that need to be controlled to ensure study success.
• Help define Key Risk Indicators (KRIs), both AbbVie standard and study specific, that will best help paint the picture of potential risk in the study.
• Bring rigor, consistency and a common risk-based vocabulary to the defining and documentation of risks to promote shared understanding and appropriate decision making.
• Leverage provided guidelines and standards for documenting the situation, the conditions under which it may occur, the risk level (how the risk is measured, the potential impact should the risk occur, and the likelihood of the risk occurrence).
• Identify inconsistent practices between studies, communicating to the Director to assist with breaking down silos.
• Participate in Health of Study Meetings.
• Translate the issue / emerging risk—the situation, the significance / implication of the data insight, and what further action is required—breaking down complex concepts into simple language.
• Communicate findings as per planned process to ensure that all cross-functional stakeholders have the same understanding of the issue / emerging risk so that the appropriate follow-up action can be taken.
• Be an RBQM and champion across AbbVie, supporting the execution of RBM processes as part of cross-functional teams spanning the R&D portfolio (all therapeutic areas and phases of development).