Central Monitoring Manager

About the role

PSI, a Contract Research Organization with almost 30 years of experience, is looking for a Central Monitoring Manager to lead the implementation of a risk-based monitoring approach on clinical studies and programs, ensuring patient safety and data integrity. The role is based in Madrid or Barcelona and is full time.

Key responsibilities

• Lead and facilitate initial and ongoing study risk management
• Take part in selecting and setting up the RBM platform
• Carry out centralized monitoring for a study, reviewing key risk indicators, statistical analyses and quality tolerance limits
• Present centralized monitoring results to study teams and clients and manage issues in a cross-functional environment
• Develop and review study-specific plans, and set up and manage targeted SDV and monitoring strategies
• Set up and manage central data review activities
• Contribute to proposals and bid defense meetings with information on risk-based monitoring services
• Communicate study challenges to the Clinical Data Science group and work out data-driven solutions

Required profile

• College or university degree, or an equivalent combination of education, training and experience
• Clinical study lead or manager experience
• Experience in centralized monitoring is a plus
• Full working proficiency in English; Spanish is a plus

Required skills

• Strong communication and presentation skills
• Leadership and ability to work independently
• Critical thinking and analytical skills
• Ability to work with complex data and give insight into risk reports and trends
• Knowledge of clinical trial processes and functions, and of protocols and study risks
• MS Office and Excel proficiency