Manager, Serious Breach

• Drive assessments and reporting of serious breach issues or events related to JJIM clinical trials to the 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 for the serious breach process
• Facilitate early consultation and timely assessment of potential serious breaches across stakeholder organizations and JJIM leadership
• Develop, assess, and report quality, efficiency, and risk performance metrics for serious breach process execution
• Monitor process controls, effectiveness, and risk management requirements to develop optimization proposals
• Deliver process improvements in collaboration with CRM and business partners including RDQA, GD, Legal, JJIMQ, and GRA
• Create and monitor digital dashboards to support 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 research, competitor process benchmarking, external reporting analysis, and serious breach training activities
• Manage projects independently and implement solutions addressing process gaps and improvement opportunities
• Engage internal and external business partners, including Health Authorities, and summarize and present results

Requirements

• 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 with 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 Tableau, Spotfire, or related data visualization tools preferred
• Ability to collect, analyze, interpret, and present data for data-driven decision making required
• High degree of accuracy and attention to detail required
• Excellent interpersonal, oral, and written communication skills required
• Proficient in Microsoft Office Applications required
• Ability to travel approximately 10%–15%, primarily domestically and/or internationally, required

Core Competencies

Demonstrates expertise in serious breach reporting and detection processes, with a strong focus on clinical trial execution, risk management, and data-driven decision making. Proficient in developing oversight strategies, monitoring capabilities, and process improvements in collaboration with cross-functional teams.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

• Clinical Trial Document Management
• Risk Management Fundamentals
• Data Analysis
• Process Optimization
• Quality Performance Metrics

Soft Skills

• Organizational Skills
• Meeting Facilitation
• Interpersonal Communication
• Attention to Detail
• Influencing Cross-Functional Teams

Industry Keywords

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

Tools & Technologies

• Tableau
• Spotfire
• Microsoft Office Applications