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工作職責: ROLE SUMMARY The Central Monitor II 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
Central Monitor I 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 Central
Monitor I 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 Execute communication plans