Central Monitoring Manager

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 meetings with information about Risk Based Monitoring services Communicate study challenges to Clinical Data Science group and work out data-driven solutions College/University degree or an equivalent combination of education, training and experience Clinical Study Lead/Manager experience Strong communication & presentation skills are essential Leadership and ability to work independently are essential Centralized Monitoring experience is a plus 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 lear