Global Clinical Risk & Quality Leader

Scorpion Therapeutics; New Jersey; On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management within R&D Quality to identify, assess, and mitigate quality risks in clinical trials across multiple therapeutic areas.

You will collaborate with trial teams to oversee risk management activities, develop Clinical Quality Plans, conduct risk monitoring, facilitate inspections, and support investigations and CAPA development, ensuring trial compliance, inspection readiness, data integrity, and the program may

Qualifications

• Bachelor’s degree in a scientific or medical discipline.
• At least 8 years of healthcare or pharma experience with proven GCP and clinical trial quality expertise.
• Strong communication, project management, and cross-cultural collaboration skills are required.
• Proficiency in MS Office; experience with risk management fundamentals, ICH guidelines, GMP/GLP/GPvP, inspections, data analytics tools, digital health, and real-world evidence.

Responsibilities

• Collaborate with trial teams to oversee risk management activities.
• Develop and review Clinical Quality Plans and conduct risk monitoring.
• Facilitate inspections and support investigations and CAPA development.
• Ensure trial compliance, inspection readiness and data integrity throughout development.

Skills

GCP expertise

Clinical quality

Project management

Cross-cultural collaboration

MS Office

Data analytics tools

ICH guidelines

Inspection experience

Digital health knowledge

Real-world evidence

Education

Bachelor's degree in science/medical field

Tools

MS Office

Risk management software

Data analytics tools

Job description

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management within R&D Quality to identify, assess, and mitigate quality risks in clinical trials across multiple therapeutic areas.

You will collaborate with trial teams to oversee risk management activities, develop Clinical Quality Plans, conduct risk monitoring, facilitate inspections, and support investigations and CAPA development, ensuring trial compliance, inspection readiness, data integrity, and the program may