Central Monitoring Manager

About the role

PSI, a leading Contract Research Organization, is seeking a Central Monitoring Manager to lead the implementation of risk‑based monitoring across clinical studies and programs. The role ensures patient safety and data integrity by overseeing centralized monitoring activities and driving data‑driven solutions.

Key responsibilities

• Lead and facilitate initial and ongoing study risk management.
• Participate in the selection and setup of the risk‑based monitoring (RBM) platform.
• Perform centralized monitoring, reviewing key risk indicators, statistical analyses and quality tolerance limits.
• Present monitoring analysis results to study teams and clients, managing issues in a cross‑functional environment.
• Develop and review study‑specific monitoring plans.
• Set up and manage targeted source data verification (SDV) and monitoring strategies.
• Coordinate central data review activities for each study.
• Contribute to proposals and bid‑defense meetings with RBM service information.
• Communicate study challenges to the Clinical Data Science group and devise data‑driven solutions.

Required profile

• College or university degree, or equivalent education and experience.
• Experience as a Clinical Study Lead or Manager.
• Strong communication and presentation abilities.
• Leadership skills and the capacity to work independently.
• Critical thinking, analytical mindset and ability to handle complex data.
• Knowledge of clinical trial processes and ability to understand protocols and associated risks.
• Full professional proficiency in English (Latvian a plus).

Required skills

• Proficiency in MS Office applications.
• Advanced Excel skills.
• Statistical analysis for risk reporting.