Senior Clinical Risk Lead - Cross-TA Programs

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 120 000 - 170 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking an Associate Director, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. The role involves coordinating identification, assessment, and mitigation of quality risks across trials and programs, ensuring data integrity and patient safety.

Based in Beerse, Belgium, the position supports inspection readiness, CAPA development, and collaboration with trial teams to deliver high-quality clinical research outcomes across multiple countries.

Qualifications

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

Responsabilités

• Participates in study activities, identifying and assessing key risks and advising on mitigations.
• Leads regular risk reviews with Risk Owners to evaluate mitigations and new risks.
• Maintains Clinical Quality Plans (CQP) in quality repository for oversight of risks and mitigations.
• Drives quality risk monitoring reviews and coaches others in risk monitoring.
• Communicates risk updates to R&D colleagues through Quality Working Groups and governance forums.
• Develops/implements CAPA plans and conducts effectiveness checks.
• Supports inspection readiness activities, including preparation of inspection narratives and site readiness.
• Provides guidance on quality investigations and SQIs per corporate standards.
• Offers training and coaching to peers and new staff.

Connaissances

GCP quality

Clinical trials

Communication

Project planning

ICH guidelines

Travel readiness

English proficiency

Formation

Bachelor’s degree in science/medical field

Outils

Microsoft Office

Description du poste

Johnson & Johnson is seeking an Associate Director, Cross Therapeutic Area Clinical Risk Management to join our R&D Quality CRM team. The role involves coordinating identification, assessment, and mitigation of quality risks across trials and programs, ensuring data integrity and patient safety.

Based in Beerse, Belgium, the position supports inspection readiness, CAPA development, and collaboration with trial teams to deliver high-quality clinical research outcomes across multiple countries.