Manager, Clinical Risk Management

Role: Manager, Cross Therapeutic Area Clinical Risk Management, supporting R&D Quality CRM at Johnson & Johnson. Responsibilities: collaborate with trial/program teams to identify, assess, and mitigate quality risks impacting trial data, patient safety, and compliance; lead risk reviews, maintain Clinical Quality Plans, support inspection readiness, and guide investigations and CAPA development. Qualifications: Bachelor’s degree in a scientific or medical discipline; 8+ years in healthcare/pharma/clinical trials; strong GCP quality and clinical trial experience; excellent communication and cross-functional collaboration skills. HighValue: focus on clinical risk management within innovative medicine, with familiarity in GxP, ICH guidelines, and inspection preparedness; experience with data analytics tools (e.g., Tableau, Spotfire) and knowledge of GMP, GLP, PV practices preferred. Work setup: based in Spring House, PA; Titusville, NJ; Raritan, NJ; or international locations (Belgium, Switzerland); up to 10% travel, mostly domestic. The role involves ensuring trial quality, compliance, and inspection readiness across multiple therapeutic areas and phases, emphasizing risk mitigation and regulatory adherence.