Senior Cross-TA Clinical Risk Manager

Johnson & Johnson Innovation; Antwerpen; Sur place; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Career growth programs

Résumé du poste

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team across Beerse, Belgium, and other locations. The role focuses on coordinating identification, assessment, and mitigation of quality risks that could affect trial data integrity and patient safety.

You will lead risk-based oversight activities, ensure regulatory compliance, and drive CAPA processes while supporting inspection readiness across trials and programs.

Qualifications

• Bachelor’s degree in a scientific, medical, or related discipline is required.
• 8+ years working in the healthcare/pharma industry is required.
• GCP quality and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills are required.
• Willingness to travel up to 10% (domestic and some international).

Responsabilités

• Identify and assess key risks in the clinical protocol/setup and advise on mitigation strategies.
• Lead risk reviews with Risk Owners to evaluate mitigations and identify new risks.
• Maintain Clinical Quality Plans (CQP) for quality governance and risk management.
• Drive quality risk monitoring and coach others in risk mitigation reviews.
• Communicate risk updates to R&D colleagues through Quality Working Groups and governance forums.
• Provide guidance on CAPA plans and ensure root cause analyses are documented.

Connaissances

Interpersonal communication

Oral communication

Written communication

Flexibility

English proficiency

Project planning

Formation

Bachelor’s degree in scientific/medical field

Outils

Microsoft Office

Tableau/Spotfire

Description du poste

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team across Beerse, Belgium, and other locations. The role focuses on coordinating identification, assessment, and mitigation of quality risks that could affect trial data integrity and patient safety.

You will lead risk-based oversight activities, ensure regulatory compliance, and drive CAPA processes while supporting inspection readiness across trials and programs.