Li Wang
Senior Central Monitor @BioMarin Pharmaceutical Inc.
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WORK HISTORY
Senior Central Monitor @BioMarin Pharmaceutical Inc.
Develop the centralized monitoring plan, incorporating feedback and discussion with the study team to capture the study requirements for centralized and statistical monitoring. • Contribute to key activities of study start up: study risk assessment & identification and definition of critical data. • Collaborate with the cross-functional study team to prepare for the Critical Data and Critical Process Definition meeting using Critical Data and Critical Process reports. Review and provide feedback focusing on items which relate to central monitoring activities and the risk mitigation approaches to monitoring at site. • Work with the CLO and CDM representatives to develop SDV/SDR strategy. • 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. • Conduct centralized monitoring per the study specific plan and quality procedures. • Support the team in assessment of centralized monitoring observations to identify potential issues and risks occurring during study conduct. • Oversight and management of all risk-based and central monitoring activities.
EDUCATION
Stony Brook University
Master, Statistics
Beihang University
Bachelor , Financial Engineering
SKILLS
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