Manager, Serious Breach Office

About This Role

Managing the Serious Breach Office is a key role in ensuring compliance with serious breach reporting requirements for clinical trials sponsored by JJIM. This position drives accountability in implementing reporting processes and facilitates the assessment of significant quality issues for reportability to health authorities. The role suits a professional with expertise in clinical risk management and operational excellence.

Responsibilities

• Drive the assessments and reporting of issues or events related to JJIM clinical trials that meet serious breach reporting criteria to the appropriate Health Authorities
• Serve as a primary subject matter expert for the JJIM organization to ensure compliance, effectiveness, and continual improvement of serious breach reporting and detection processes
• Define, drive, and enhance oversight strategies and monitoring capabilities to ensure the effectiveness and compliance elements of the serious breach process within the clinical trial risk and issue management framework
• Facilitate early consultation and timely assessment activities across stakeholder organizations and varying levels of JJIM leadership to ensure the appropriate dispositioning of potential serious breaches
• Develop, assess, and report performance metrics related to quality, efficiency, and risk for serious breach process execution and timely case reporting, identifying process and/or compliance strengths and gaps for management review
• 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
• Identify and deliver key improvements to the serious breach process in collaboration with CRM and key business partners (RDQA, GD, Legal, JJIMQ, and GRA)
• Collaborate with stakeholders to create and monitor meaningful digital dashboards that enable clear interpretation and data-driven decision making
• Represent the Serious Breach Office during process, strategic, and/or data reviews, modeling appropriate preparedness, executive presence, confidence, and assertiveness to enable efficient, data-driven decisions and actions
• 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
• Represent the function in support of core RDQ and business partner initiatives
• Conduct vigilant continuing education and research into the regulatory landscape of serious breach reporting, competitor process benchmarking, external reporting analysis, and JJIM serious breach training platforms
• Interpret problems, create proposals, and implement solutions that effectively address gaps and/or areas of potential improvements