Manager, Serious Breach

• Facilitate serious breach assessments and reporting for JJIM-sponsored clinical trials to appropriate Health Authorities
• Serve as a primary subject matter expert for serious breach reporting and detection processes
• Define, drive, and enhance oversight strategies and monitoring capabilities within the clinical trial risk and issue management framework
• Facilitate early consultation and timely assessment across stakeholder organizations and JJIM leadership
• Develop, assess, and report performance metrics for quality, efficiency, risk, and timely case reporting
• Monitor process controls, effectiveness, and risk management requirements to identify optimization opportunities
• Deliver improvements to the serious breach process with CRM and business partners including RDQA, GD, Legal, JJIMQ, and GRA
• Create and monitor digital dashboards to support interpretation and data-driven decision-making
• Represent the Serious Breach Office in process, strategic, and data review meetings
• Develop templates, scorecards, and dashboards with RDQ and R&D stakeholders
• Represent CRM-OpEx in core RDQ and business partner initiatives
• Conduct regulatory landscape research, competitor benchmarking, external reporting analysis, and serious breach training activities
• Manage projects independently and present results to internal, external, and Health Authority stakeholders

• Bachelor's degree in a scientific, medical, or related discipline required
• Minimum of 1–3 years of relevant health care industry experience required
• Pharmaceutical, medical device, biologics company, and/or Health Authority experience required
• Experience in clinical trial execution, clinical trial document management, and/or GCP compliance preferred
• Strong organizational and project management skills required
• Strong meeting facilitation skills required
• Experience leading and influencing complex, cross-functional teams required
• Experience with clinical trial risk management fundamentals, serious breach reporting requirements, and corresponding ICH guidelines required
• Proficiency with data visualization tools such as Tableau or Spotfire preferred
• Ability to collect, analyze, interpret, and present data required
  
  High degree of accuracy and attention to detail required
• Excellent interpersonal, oral, and written communication skills required
• Proficiency in Microsoft Office applications required
• Ability to travel approximately 10%–15%, primarily domestically and/or internationally, required

Demonstrates expertise in serious breach reporting and clinical trial risk management, with a strong focus on data analysis, project management, and stakeholder communication. Proficient in developing performance metrics and utilizing data visualization tools to enhance decision-making processes.

• Serious Breach Reporting
• Clinical Trial Risk Management
• Data Visualization Tools
• Project Management
• GCP Compliance

• Clinical Trial Execution
• Data Analysis
• Performance Metrics Development
• Regulatory Landscape Research
• Serious Breach Training
• Document Management
• Risk Management Fundamentals
• Meeting Facilitation
• Interpreting Data
• Attention to Detail

• Organizational Skills
• Interpersonal Communication
• Written Communication
• Leadership
• Influencing Teams

• Pharmaceutical
• Medical Device
• Biologics
• Health Authority
• ICH Guidelines

• Tableau
• Spotfire
• Microsoft Office