Global Clinical Risk Management Lead

Johnson Johnson; Madrid; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team. The role focuses on identifying and mitigating risks across clinical programs, with global collaboration and a strong emphasis on quality and compliance.

The position requires extensive experience in GCP and clinical trials, with the ability to lead risk reviews, develop CAPA plans, and support inspections across multiple sites.

Competenze

• Bachelor's degree required.
• 8+ years in healthcare/pharma/clinical settings.
• GCP Quality/clinical trials experience required.
• Excellent interpersonal and written communication skills.
• Flexible to changing business needs.
• Experience with ICH guidelines preferred.
• Proficiency in MS Office applications.

Mansioni

• Participate in study activities to identify key risks in protocol/setup and advise on mitigation strategies.
• Lead regular risk area reviews with Risk Owners to evaluate mitigations and identify new risks.
• Maintain Clinical Quality Plans (CQP) in quality repository for progress reviews.
• Drive quality risk monitoring reviews and coach others on mitigations.
• Communicate risk updates to RDQ CRM and Governance Forums.
• Develop CAPA plans and effectiveness checks with RDQ partners.
• Support inspection readiness activities and post-inspection support.

Conoscenze

GCP Knowledge

Clinical Trials

Communication

English Proficiency

Project Management

Data Analytics

Formazione

Bachelor's degree

Strumenti

Tableau

Spotfire

MS Office

Descrizione del lavoro

Johnson & Johnson is seeking a Manager, Cross Therapeutic Area Clinical Risk Management to join the R&D Quality CRM team. The role focuses on identifying and mitigating risks across clinical programs, with global collaboration and a strong emphasis on quality and compliance.

The position requires extensive experience in GCP and clinical trials, with the ability to lead risk reviews, develop CAPA plans, and support inspections across multiple sites.