Central Monitoring Manager

PSI CRO

14h

About The Position

PSI is seeking a Central Monitoring Manager to lead implementation of risk-based monitoring at the clinical study and program levels, helping ensure patient safety and data integrity. The role includes leading and facilitating study risk management, performing centralized monitoring, and presenting analyses to study teams and clients. The manager also develops study-specific plans and monitoring strategies, oversees central data review activities, contributes to proposals and bid defense meetings, and works with Clinical Data Science to develop data-driven solutions to study challenges. The position offers an opportunity to work on the front line of the industry and gain a global view of projects.

Requirements

• College or university degree, or an equivalent combination of education, training, and experience.
• Clinical study lead or 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, including the 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.

Responsibilities

• Lead and facilitate initial and ongoing study Risk Management.
• Participate in selection and setup of the risk-based monitoring (RBM) platform.
• Perform centralized monitoring for studies, including reviewing 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 source data verification (SDV) and monitoring strategies for studies.
• Set up and manage central data review activities in studies.
• 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
• Education Level: No Education Listed