Central Monitoring Manager

About the role

PSI, a Contract Research Organization with more than 25 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. Applications must be submitted in English.

Key responsibilities

• Lead and facilitate initial and ongoing study risk management
• Take part in selecting and setting up the RBM platform
• Perform 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 in a study
• 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
• Strong communication and presentation skills, leadership and ability to work independently
• Full working proficiency in English

Required skills

• 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 ability to understand protocols and study risks
• Ability to adapt to change and learn quickly
• Proficiency in MS Office applications and Excel