Manager, Serious Breach

Jobtailor; Beerse; Sur place; EUR 52 000 - 76 000; Plein temps

Résumé du poste

Jobtailor is seeking an expert to drive serious breach reporting for JJIM clinical trials in collaboration with Health Authorities. You will act as the SME for breach reporting and detection, shaping oversight strategies, and delivering data-driven insights.

Responsibilities include developing metrics, dashboards, and templates with RDQ, R&D, and CRM partners, while coordinating with cross-functional teams to ensure GCP compliance and timely regulatory communication.

Qualifications

• Bachelor's degree in a scientific, medical, or related discipline is required.
• 1–3 years of health care industry experience is required.
• Pharmaceutical/medical device/health authority experience is required.
• Experience with clinical trial execution/document management/GCP is preferred.
• Strong organizational and project management skills are required.
• Excellent interpersonal, oral, and written communication skills are required.

Responsabilités

• Drive assessments and reporting of serious breach issues to Health Authorities.
• Serve as SME for serious breach reporting and detection processes.
• Define, drive, and enhance oversight strategies for the serious breach process.
• Facilitate early consultation and timely assessment of potential serious breaches across stakeholders.
• Develop metrics and dashboards for risk performance and process execution.
• Monitor controls and risk management requirements to propose optimizations.
• Collaborate with CRM and business partners to implement process improvements.
• Create dashboards to support data-driven decision making.
• Represent the Serious Breach Office in meetings with leadership and stakeholders.
• Develop templates, scorecards, and dashboards with RDQ and R&D stakeholders.
• Represent CRM-OpEx in RDQ and business partner initiatives.
• Conduct regulatory research and external reporting analysis.
• Manage projects independently and address process gaps and improvement opportunities.
• Engage internal/external partners including Health Authorities and summarize results.

Connaissances

Serious Breach Reporting

Clinical Trial Execution

Project Management

Data Visualization

GCP Compliance

Formation

Bachelor's degree in a scientific, medical, or related discipline

Outils

Tableau

Spotfire

Microsoft Office

Description du poste

• 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