Senior Associate, Senior Central Monitor, Risk Based Monitoring

Pfizer — India - Chennai

ROLE SUMMARY The Senior Central Monitor is responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Senior Central Monitor ensures risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Senior Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Central Monitor works with the global study team to meet the study objectives. ROLE RESPONSIBILITIES General: Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables. Provide technical expertise to set up and test study level Risk-based Monitoring system Review study level system outputs to process for the signal and action management Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study. Able to resolve conflicts, influence and communicate with key stakeholders and customers. Implement quality oversight/control steps implemented in the central monitor activities. System setup Functions: Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized. Provide technical oversight, guidance and coordination for all the central monitor activities. Set up and test RBM system at

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