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