Risk Management Lead - Hybrid

Responsibilities

• 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.
• 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).
• Through Therapeutic Alignment, ensure communication and consistency in Program/Compound level Risk through partnerships with cross-functional stakeholders and maintain the Risk Library.
• **This is a hybrid based role working on-site T-TH. Candidates must be local to Marlow and work on-site 3 days a week.
• Bachelor's degree in life sciences, risk-based, or related discipline; advanced degree preferred.
• 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 ini

Benefits

Additional Information

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

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