Central Monitoring Manager

Job description

Company Description PSI is a leading Contract Research Organization with almost 30 years on the market, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description: With the industry moving forward, the central monitoring function has become a top priority at PSI. We are looking for a person, who would lead the risk-based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity. You will: - Lead and facilitate initial and ongoing study Risk Management - Participate in selection and setup of 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 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 to Proposals and bid defense mee...