Job Posting Title Manager, Clinical Risk Management

Johnson & Johnson seeks a Manager for Cross Therapeutic Area Clinical Risk Management to oversee quality risk identification, assessment, and mitigation across clinical trials and programs. The role ensures trial data integrity, patient safety, regulatory compliance, and inspection readiness across multiple R&D locations.

Responsibilities

• Identify, assess, and mitigate quality risks impacting trial data integrity and patient safety with trial and program teams
• Lead regular risk area reviews with Risk Owners to evaluate mitigation progress and identify emerging risks
• Maintain Clinical Quality Plans and drive risk monitoring reviews independently
• Manage quality investigations, significant quality issues escalation, and CAPA plan development
• Support inspection readiness activities including mock inspections, inspection narratives, and post-inspection follow-up

Requirements

• Bachelor's degree in scientific, medical, or related discipline
• Minimum 8 years healthcare industry experience (pharma, CRO, or hospital systems)
• Strong GCP Quality and clinical trials experience
• Excellent interpersonal, oral, and written communication skills
• Proficiency in Microsoft Office Applications
• Ability to work effectively in culturally diverse, cross-functional environments
• Experience with clinical trial risk management fundamentals preferred