Manager, Clinical Risk Management

Scorpion Therapeutics; Spring House (PA); On-site; USD 120,000 - 170,000; Full time

Job summary

Johnson & Johnson in the US seeks a Manager, Cross Therapeutic Area Clinical Risk Management within the R&D Quality CRM team to oversee risk management for global clinical trials, ensuring data integrity and patient safety. You will lead risk reviews, craft mitigation plans, and mentor teams, supporting inspection readiness and quality investigations across regions to uphold regulatory compliance.

This on-site role includes up to 10% travel and opportunities to influence global program quality

Qualifications

• 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.

Responsibilities

• 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.

Skills

Communication skills

Risk management fundamentals

Data analytics

Education

Bachelor's degree in a scientific or medical discipline

Tools

Microsoft Office

Job description

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.

Responsibilities

• 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.

Requirements

• 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.

Preferred

• 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.

HighValue: 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.