Cross-TA Clinical Risk Leader

Johnson & Johnson Innovation; Madrid; Sur place; EUR 55 000 - 95 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson in Madrid seeks a Manager, Cross TA Clinical Risk Management to join our R&D Quality CRM team. The role coordinates risk identification, assessment, and mitigation across trials to protect data integrity and patient safety.

You will work with trial teams to monitor risk, develop CAPA plans, support inspections, and ensure regulatory compliance. A Bachelor's in a scientific field and at least 8 years in healthcare, with GCP/trial experience and strong communication, are

Qualifications

• Bachelor's degree in scientific, medical, or related discipline is required.
• Proven experience in GCP quality and/or clinical trials is required.
• Excellent interpersonal, oral, and written communication skills are required.
• Flexibility to adapt to changing business needs and diverse global teams.
• Proficiency with data analytics tools for inspection readiness is preferred.

Responsabilités

• Coordinate identification, assessment, and mitigation of quality risks across trials/programs.
• Lead risk reviews with Risk Owners and maintain Clinical Quality Plans.
• Develop and implement CAPA plans and effectiveness checks.
• Support inspections and prepare inspection narratives and key documents.
• Provide guidance on quality investigations and regulatory compliance.

Connaissances

GCP quality knowledge

Clinical trials experience

English proficiency

Project management

Data analytics tools familiarity

Formation

Bachelor's degree in scientific, medical or related discipline

Outils

Microsoft Office

Description du poste

Johnson & Johnson in Madrid seeks a Manager, Cross TA Clinical Risk Management to join our R&D Quality CRM team. The role coordinates risk identification, assessment, and mitigation across trials to protect data integrity and patient safety.

You will work with trial teams to monitor risk, develop CAPA plans, support inspections, and ensure regulatory compliance. A Bachelor's in a scientific field and at least 8 years in healthcare, with GCP/trial experience and strong communication, are