Associate Central Monitor, Data Surveillance, Clinical Data Sciences
CurrentGeneral:• Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables. • Assist to set up and test study level Risk-based Monitoring system. • Execute communication plans & methods to meet study requirement. • Assist to resolve conflicts, influence and communicate with key stakeholders and customers. System setup Functions:• Set up and test RBM system at… Show more General:• Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables. • Assist to set up and test study level Risk-based Monitoring system. • Execute communication plans & methods to meet study requirement. • Assist to resolve conflicts, influence and communicate with key stakeholders and customers. System setup Functions:• Set up and test RBM system at study level to ensure system quality. • Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level. • Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements. Data review Functions:• Implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy. • Assist to central monitoring activities including review system outputs, signal and action management. Show less