Manager, Clinical Risk Management

apartmentJohnson & Johnson placeMadrid calendar_month 

Experteer Overview

As Manager, Cross Therapeutic Area Clinical Risk Management, you drive risk identification, assessment, and mitigation across trials and programs to protect data integrity and patient safety. You will work with trial teams and RDQ CRM to ensure ongoing quality, regulatory compliance, and inspection readiness.

You’ll lead risk reviews, guide CAPA plans, and support inspections, contributing to safer, compliant clinical development. This role spans multiple countries, offering broad impact in shaping therapeutic programs.

Compensaciones / Beneficios
  • Coordinate identification, assessment, and mitigation of quality risks across trials/programs
  • Lead regular risk reviews with Risk Owners to track mitigations and identify new risks
  • Maintain Clinical Quality Plans (CQP) in quality repository and monitor quality support services
  • Drive risk monitoring reviews and coach others in risk assessment
  • Communicate risk updates to R&D colleagues via Quality Working Groups and governance fora
  • Advise on development/implementation of CAPA plans and effectiveness checks
  • Support inspection readiness activities, site preparation, and mock inspections in collaboration with Regulatory Compliance
  • Provide independent guidance on research quality and compliance with international regulations
Responsabilidades
  • Bachelor degree in scientific/medical or related discipline
  • 8+ years in healthcare/pharmaceutical industry or related settings
  • Proven GCP quality and/or clinical trials experience
  • Excellent interpersonal, oral, and written communication
  • Flexibility to adapt to changing business needs
  • Ability to operate in culturally diverse global teams
  • Proficiency in Microsoft Office
  • Experience with clinical trial risk management and knowledge of ICH guidelines (preferred)
  • Knowledge of GMP/GLP/GPvP (preferred)
  • English proficiency; up to 10% travel (domestic/international)
  • Experience with data analytics/visualization tools (Tableau, Spotfire) (preferred)
  • Experience with Data Science/Digital Health (including real-world evidence) (preferred)
Requisitos principales
  • 8% holiday allowance
  • attractive benefits
  • competitive compensation
  • tailored benefits across life stages
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