Sr. CRA @ Samumed, LLC (March 2017 - February 2019)
CRA II @ Samumed, LLC (February 2016 - March 2017)
CRA I @ Samumed, LLC (July 2013 - February 2016)
Scientific Translator @ (January 2012 - June 2013)
Yiwen Sun Education
UCSD 2006-2011
Yiwen Sun Skills
Clinical Risk Management
Clinical Trial Management System (CTMS)
Clinical Operations
ICH GCP
Project Management
Program Management
Cross-functional Team Leadership
Analytical Skills
Identifying Trends
Contract Research Organization (CRO)
Electronic Trial Master File (eTMF)
Clinical Management
Trial Master File (TMF)
ICH
Quality Metrics
Issue Management
Continuous Improvement
KRI
QTL
RACT
CAPAs
Design Failure Mode and Effect Analysis (DFMEA)
Root Cause
Risk Analysis
Contingency Planning
Key Opinion Leaders
Clinical Study Management
PCR
Agarose Gel Electrophoresis
recombinant DNA technology
Gel Electrophoresis
Western Blotting
Restriction Digestion
Plasmid Isolation
SDS-PAGE
Biochemistry
Molecular Biology
Cell Culture
Tissue Culture
Protein Chemistry
Cell Biology
ELISA
Purification
Fluorescence Microscopy
Biotechnology
Lifesciences
Laboratory
DNA sequencing
Protein Purification
Drug Discovery
Immunohistochemistry
Pharmacology
Risk Assessment
Risk Management
Clinical Trials
Clinical Development
Pharmaceutical Industry
Good Clinical Practice (GCP)
Clinical Research
U.S. Food and Drug Administration (FDA)
Sds Page
u.s. Food and Drug Administration
Good Clinical Practice
Yiwen Sun Summary
Yiwen Sun, based in San Diego, CA, US, is currently a Associate Director, Risk-Based Quality Management (RBQM) at BeiGene. Yiwen Sun brings experience from previous roles at Biosplice Therapeutics and Samumed, LLC. Yiwen Sun holds a 2006 - 2011 UCSD. With a robust skill set that includes Clinical Risk Management, Clinical Trial Management System (CTMS), Clinical Operations, ICH GCP, Project Management and more. Yiwen Sun has 2 emails and 1 mobile phone numbers on RocketReach.
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