Manager, Clinical Risk Management

Role:
Manager, Cross Therapeutic Area Clinical Risk Management within Johnson & Johnson's R&D Quality CRM team, focused on overseeing quality risk processes in clinical trials across multiple regions.

• identify, assess, and mitigate risks affecting data integrity, patient safety, and trial compliance;
• lead risk reviews, develop risk mitigation strategies, and maintain Clinical Quality Plans;
• support inspection readiness activities, including mock inspections and post-inspection follow-up;
• provide guidance on quality investigations, CAPA development, and escalation of significant issues;
• collaborate across global teams and ensure regulatory compliance per ICH, GxP, and relevant standards.

• bachelor’s degree in a scientific or medical discipline;
• 8+ years in healthcare or pharma industries with proven GCP quality/trial experience;
• strong communication skills;
• proficiency in Microsoft Office;
• experience with risk management fundamentals and working in regulated environments.

• familiarity with ICH guidelines, GMP, GLP, PV practices;
• inspection experience (FDA, EMA);
• project management skills;
• data analytics proficiency;
• knowledge of digital health and real-world evidence.

High Value: clinical trial risk management, GCP expertise, inspection readiness, international regulatory compliance, cross-functional collaboration, and experience in global pharma or CRO settings.

Work setup: primarily on-site with up to 10% travel, mainly domestic and some international.