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Liyan Hu
Life Science Consultant

Liyan Hu.png
  • LinkedIn
  • 6+ years in academic research in the areas of human diseases in Germany and Switzerland (Inherited Metabolic Rare Diseases, Cancer, Hematology)

  • Practicing resident physician in Chinese hospital (Hangzhou)

  • Freelance contractor for multiple projects

Specialties
  • (e)TMF assessment & management

  • GCP audit

  • SOP development & management

  • Clinical Trial Management

  • Clinical and scientific data analysis

Experience
  • Conducted GCP co-auditing at trial sites and CROs in Europa (Spain, Germany and Switzerland)

  • Conducted several paper and electronic Trial Master File (eTMF) completeness assessment audits and their gap analysis for diverse clinical phases of international clinical trials

  • Maintained the documentation system by co-drafting and updating quality assurance policies and standard operating procedures (SOPs)

  • Supported implementation and maintenance of internal Quality Management System (QMS)

  • Provided QC support for Chinese-English bilingual documents including SOPs, Policies, Guidelines and Quality Manual

  • Worked across all functions to ensure that quality standards are maintained within the organizations

  • Coordinated scientific symposia and other seminars

  • Collaborated with local and international research laboratories

  • Assisted budget and resource management

  • Conducted market research on customer experiences (with Chinese hospitals) to further develop a service strategy for a Chinese pharmaceutical company

  • Optimized the study designs and implementation process

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