Manager, Clinical Risk Management

Scorpion Therapeutics; Raritan (NJ); On-site; USD 110,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Manager for Cross Therapeutic Area Clinical Risk Management within R&D Quality CRM to oversee risk Identification, assessment, and mitigation across multiple trials and programs. You will collaborate with trial teams to maintain trial quality, ensure patient safety, and drive CAPA investigations while aligning with GxP, ICH guidelines, and inspection readiness.

Based in Spring House, PA; Titusville, NJ; or Raritan, NJ, with opportunities for international postings

Qualifications

• Bachelor’s degree in a scientific or medical discipline.
• 8+ years in healthcare/pharma/clinical trials.
• GCP quality and clinical trial experience.

Responsibilities

• Identify, assess, and mitigate quality risks impacting trial data, patient safety, and compliance.
• Lead risk reviews and maintain Clinical Quality Plans.
• Support inspection readiness and guide investigations and CAPA development.

Skills

GCP quality

Clinical trial experience

Cross-functional collaboration

Communication

Education

Bachelor's degree in a scientific or medical discipline

Tools

Tableau

Spotfire

Job description

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.