Liyan Hu
Life Science Consultant
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6+ years in academic research in the areas of human diseases in Germany and Switzerland (Inherited Metabolic Rare Diseases, Cancer, Hematology)
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Practicing resident physician in Chinese hospital (Hangzhou)
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Freelance contractor for multiple projects
Specialties
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(e)TMF assessment & management
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GCP audit
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SOP development & management
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Clinical Trial Management
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Clinical and scientific data analysis
Experience
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Conducted GCP co-auditing at trial sites and CROs in Europa (Spain, Germany and Switzerland)
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Conducted several paper and electronic Trial Master File (eTMF) completeness assessment audits and their gap analysis for diverse clinical phases of international clinical trials
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Maintained the documentation system by co-drafting and updating quality assurance policies and standard operating procedures (SOPs)
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Supported implementation and maintenance of internal Quality Management System (QMS)
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Provided QC support for Chinese-English bilingual documents including SOPs, Policies, Guidelines and Quality Manual
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Worked across all functions to ensure that quality standards are maintained within the organizations
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Coordinated scientific symposia and other seminars
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Collaborated with local and international research laboratories
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Assisted budget and resource management
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Conducted market research on customer experiences (with Chinese hospitals) to further develop a service strategy for a Chinese pharmaceutical company
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Optimized the study designs and implementation process