CENTRAL MONITORING MANAGER

<p>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.</p><p><strong>You will:</strong></p><ul><li>Lead and facilitate initial and ongoing study Risk Management</li><li>Participate in selection and setup of the RBM platform</li><li>Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits</li><li>Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environment</li><li>Develop and review study-specific Plans</li><li>Set up and manage targeted SDV and monitoring strategy for a study</li><li>Set up and manage Central Data Review activities in a study</li><li>Contribute to Proposals and bid defense meetings with information about Risk Based Monitoring services</li><li>Communicate study challenges to Clinical Data Science group and work out data-driven solutions</li></ul> <ul><li>College/University degree or an equivalent combination of education, training and experience</li><li>Clinical Study Lead/Manager experience</li><li>Strong communication &amp; presentation skills are essential</li><li>Leadership and ability to work independently are essential</li><li>Centralized Monitoring experience is a plus</li><li>Critical thinking and analytical skills</li><li>Ability to work with complex data and provide insight into risk reports and trends</li><li>Ability to adapt to changing circumstances and learn quickly</li><li>Knowledge of the&#xa0;process&#xa0;and functions in clinical trials, ability to understand the protocol and study associated risks</li><li>Full working proficiency in English (Spanish&#xa0;proficiency is a plus)</li><li>Proficiency in MS Office applications,&#xa0;Excel skills</li></ul> <p>This role is not only important for every CRO, but it is booming now. This is an opportunity to work on a frontline of the industry, set the grounds for risk-based models&#xa0;and get a global helicopter view on each project.</p>