Senior Manager, Cross-TA Clinical Risk & Quality

Johnson & Johnson Innovation; New Jersey; Hybrid; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Cross TA Clinical Risk Management to join the R&D Quality CRM team. The role oversees risk identification, assessment, and mitigation across trials/programs, ensuring data integrity, patient safety, and compliance with regulatory requirements.

The position involves coordinating with trial teams, risk owners, and governance forums, with travel up to 10% and a focus on inspection readiness and CAPA activities.

Qualifications

• Bachelor’s degree in scientific, medical, or related discipline.
• 8+ years working in healthcare/pharma/CRO or healthcare system.
• Proven strong GCP quality and/or clinical trials experience.
• Excellent interpersonal, oral, and written communication skills.
• Proficiency with Microsoft Office applications.
• Travel up to 10% and flexibility to work across locations.

Responsibilities

• Actively participates in study activities to identify and assess key risks and advise on mitigation.
• Leads regular risk reviews with Risk Owners and identifies new risks or mitigation needs.
• Maintains Clinical Quality Plans in the quality repository for ongoing reviews.
• Drives quality risk monitoring reviews and coaches others in risk monitoring.
• Communicates risk updates to R&D colleagues through Quality Working Groups and governance fora.
• Develops and ensures consistent interpretation of issues requiring quality investigations.
• Provides guidance on CAPA plans and effectiveness checks.

Skills

GCP Quality

Clinical trials

Interpersonal skills

Project management

English proficiency

Regulatory understanding

Flexibility

Data analytics tools

Education

Bachelor’s degree in science/medicine

Tools

Tableau

Spotfire

Job description

Johnson & Johnson is seeking a Manager, Cross TA Clinical Risk Management to join the R&D Quality CRM team. The role oversees risk identification, assessment, and mitigation across trials/programs, ensuring data integrity, patient safety, and compliance with regulatory requirements.

The position involves coordinating with trial teams, risk owners, and governance forums, with travel up to 10% and a focus on inspection readiness and CAPA activities.