Manager, Clinical Risk Management

Location: Madrid, Spain; hybrid work from a J&J office. The role is also available in the United States, Belgium, and Switzerland, with up to 10% domestic and international travel.

Base pay range: €61,800–€106,260 annually.

Company

Johnson & Johnson develops healthcare and Innovative Medicine solutions, including treatments and clinical programs designed to improve patient health.

What you will do

• Coordinate the identification, assessment, monitoring, and mitigation of quality risks across clinical trials and programs.
• Lead risk reviews with Risk Owners and maintain Clinical Quality Plans in the quality repository.
• Advise clinical teams on quality investigations, significant quality issues, CAPA plans, and effectiveness checks.
• Communicate risk updates through Quality Working Groups and governance forums, escalating systemic risks to senior R&D management.
• Drive inspection readiness, including inspection narratives, site preparation, document availability, mock inspections, and post-inspection support.
• Provide independent guidance on research quality, compliance, and international regulations.

Requirements

• Bachelor’s degree in a scientific, medical, or related discipline.
• At least 8 years of experience in healthcare, pharmaceuticals, contract research, or a healthcare/hospital system.
• Strong GCP quality and/or clinical trials experience.
• Strong interpersonal, written, oral communication, project planning, and cross-functional collaboration skills.
• Proficiency in Microsoft Office and English speaking and writing proficiency.
• Ability to work with culturally diverse teams and regional and global business structures.

Nice to have

• Clinical trial risk management and ICH guideline experience.
• Knowledge of GMP, GLP, or GPvP and experience with FDA, EMA, or other health authority inspections.
• Experience with escalations, CAPA support, data analytics, or data visualization tools such as Tableau or Spotfire.
• Experience with Data Science, Digital Health, Real World Evidence, or Real World Disease.

Culture & Benefits

• Inclusive work environment focused on diversity, dignity, and equal opportunity.
• Annual bonus or sales commissions depending on pay grade and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Recognition awards and access to applicable insurance plans.