Risk

• Business Process Ownership (BPO) : As the designated Clinical Quality Plan BPO, you will define, drive and enhance oversight strategies and monitoring capabilities to ensure the effectiveness and compliance elements of the CRM clinical trial risk management framework and Quality Support Services.
• Performance Monitoring : As the Chair, facilitator or contributor to relevant Risk Management governance forums, you will develop, assess and report performance metrics related to quality, efficiency, and risk, identifying process and/or compliance strengths and gaps for management review.
• Continual Improvement Driver : As a steward of continual process improvement, you will monitor adherence to implemented process controls, effectiveness and risk management requirements in alignment with associated business partner processes, enterprise standards and industry regulations to develop proposals for optimization initiatives. You will identify and deliver key improvements to the Clinical Quality Plan process in collaboration with CRM, and key business partners.
• Data Analysis and Visualization : As a presenter and primary monitor of CRM metrics and KPIs, you will collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making.
• Leadership in Meetings : As a Chair of the CRM Governance forums and Serious Breach assessments, you will model the appropriate level of preparedness, executive presence, confidence and assertiveness to thoroughly enable efficient, data-driven decisions and actions.
• Collaboration : As part of the RDQ and broader J&J community, you will partner with RDQ QANA, R&D stakeholders and other potential sources of benefit from across IM and MedTech to develop templates, scorecards, and dashboards that simplify activities for functional teams and contributors.
• Strategic Support : As a Leader within the CRM-OpEx team, you will represent your function in support of core RDQ and business partner objectives and initiatives.
• Serious Breach Office (SBO): As a facilitator and record owner, you will adhere to the process and take ownership to drive the assessments and reporting of issues or events that are provided to the SBO for potential reportability to various Health Authorities.

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