Central Monitoring Manager

PSI CRO

1d

About The Position

PSI is seeking a Central Monitoring Manager to lead implementation of risk-based monitoring approaches at the clinical study and program levels, helping ensure patient safety and data integrity. The role includes centralized monitoring, risk management, development of study-specific plans and strategies, and collaboration with study teams, clients, and Clinical Data Science. The position offers the opportunity to help establish risk-based models and gain a global view of projects.

Requirements

• College/University degree, or an equivalent combination of education, training, and experience.
• Clinical Study Lead/Manager experience.
• Strong communication and presentation skills.
• Leadership ability and ability to work independently.
• Critical thinking and analytical skills.
• Ability to work with complex data and provide insight into risk reports and trends.
• Ability to adapt to changing circumstances and learn quickly.
• Knowledge of clinical trial processes and functions, and ability to understand protocols and associated study risks.
• Full working proficiency in English.
• Proficiency in MS Office applications, including Excel skills.
• Applications must be submitted in English.

Nice To Haves

• Centralized Monitoring experience.
• Lithuanian proficiency.

Responsibilities

• Lead and facilitate initial and ongoing study Risk Management.
• Participate in selecting and setting up the RBM platform.
• Perform Centralized Monitoring for a study, including review of Key Risk Indicators, Statistical Analyses, and Quality Tolerance Limits.
• Present Centralized Monitoring analysis results to study teams and clients, and manage issues in a cross-functional environment.
• Develop and review study-specific plans.
• Set up and manage targeted SDV and monitoring strategy for a study.
• Set up and manage Central Data Review activities in a study.
• Contribute information about Risk Based Monitoring services to proposals and bid defense meetings.
• Communicate study challenges to the Clinical Data Science group and develop data-driven solutions.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager