Serious Breach Office Manager: Clinical Risk & Compliance

Scorpion Therapeutics; Horsham (PA); Hybrid; USD 120,000 - 165,000; Full time

Job summary

Johnson & Johnson's Clinical Risk Management team seeks a Manager of the Serious Breach Office to oversee compliance, process oversight, and continuous improvement of serious breach reporting for JJIM-sponsored clinical trials.

The role coordinates breach assessments, ensures timely reporting to health authorities, develops performance metrics, and leads process optimization with cross-functional teams across regions.

Qualifications

• Bachelor's degree in a scientific or medical field.
• 1–3 years of relevant experience in healthcare, pharma, medical devices, or biologics.
• Knowledge of clinical trial risk management, GCP, and serious breach reporting guidelines (ICH).

Responsibilities

• Facilitate breach assessments and ensure timely reporting to health authorities.
• Develop performance metrics and dashboards for serious breach management.
• Lead process optimization initiatives and drive continuous improvement.
• Perform data analysis and collaborate with stakeholders; represent SBO in strategic meetings.

Skills

Organizational skills

Project management

Stakeholder engagement

Communication

Data visualization

Education

Bachelor's degree in science

Tools

Tableau

Spotfire

Job description

Johnson & Johnson's Clinical Risk Management team seeks a Manager of the Serious Breach Office to oversee compliance, process oversight, and continuous improvement of serious breach reporting for JJIM-sponsored clinical trials.

The role coordinates breach assessments, ensures timely reporting to health authorities, develops performance metrics, and leads process optimization with cross-functional teams across regions.