The Senior Study Risk Lead is the risk management subject matter expert for study execution and central monitoring in AbbVie鈥檚 end-to-end Risk-based Quality Management (RBQM) model鈥攁 critical pillar required in AbbVie鈥檚 mission to be a world-class R&D organization. The Senior Study Risk Lead serves as an RBQM expert and leader to functional departments in the execution and sustainability of AbbVie's end to end RBQM model and partners with the cross functional study team and drives study implementation of RBQM processes with Central Monitoring team and cross-functional study teams. The purpose of the Senior 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 and to support study risk leads in delivery and supports the study risk leads through mentoring and coaching.
Responsibilities:
- Responsible for multiple-jurisdiction studies with sites across the globe. Serve as a leader to functional departments in embedding the end to end RBQM model and support sustainability. Partner with cross-functional leaders in the development of risk management strategies across a TA or program, 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.
- Drive and contribute to the development, embedding, growth and health of the necessary business process to support risk-based quality management and global monitoring processes. Lead or Co-lead RBQM initiatives and workstreams focusing on quality and risk management. Serve as Business process expert to ensure end-to-end RBQM is aligned throughout the business process framework.
- Analyze RBQM key performance indicators and support cross-functional stakeholders in deep-dive analysis , leading indicators and the development of action plans as needed, support the development of inspection responses and CAPA development for RBQM processes.
- Coach and mentor junior and peer Study Risk Leads. Develop RBQM training and materials for Study Risk Leads and other cross-functional stakeholders including Forum and training facilitation. Facilitate the Risk Management meetings (initial and ongoing).
- Support the cross-functional study team in identifying potential risks and mitigation planning in the development of the Risk Assessment and Mitigation Plan with a focus on data integrity and patient safety. 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 new emerging risks.
- Support the study team ensuring identified risk inform RBQM component development and 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. Assist the study team to define Key Risk Indicators (KRIs), both AbbVie standard and study-specific and establish Quality Tolerance Limits (QTLs) that will best help determine risk.
- 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).
- Through Therapeutic Alignment, ensure communication and consistency in Program/Compound level Risk through partnerships with cross-functional stakeholders and maintain the Risk Library.
- Be an RBQM leader across AbbVie, driving the adoption of AbbVie鈥檚 RBQM framework and process evolution across R & D as part of the cross-functional teams spanning the portfolio (all therapeutic areas and phases of development). Collaborate with Central Monitoring and Study Risk Management leadership in bringing solutions and strategies focused on quality and risk management.
**This is a hybrid based role working on-site T-TH. Candidates must be local to Lake County, IL or Irvine, CA and work on-site 3 days a week.