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Heidi Liu, M.D
Quality Assurance, Global Lead, China

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  • LinkedIn
  • 8 years of industry experience with J&J, Pfizer and GSK in clinical quality planning and strategy, quality risk management and GCP audit

  • 3 years of research institution experience with Shanghai HuaShan Hospital and Peking University in Human Research Protection Program

  • 3 years at Forum for Ethical Review Committee in Asia and the Western Pacific Region (FERCAP) in ethics committee recognition program

  • 5 years as clinical monitor & auditor for WHO TDR clinical research projects

  • 7 years as General Physician at Shanghai Zhongshan Hospital

  • Quality Risk Management & Quality by Design

  • Process analysis and re-engineering

  • Clinical Trial Management & Monitoring

  • IRB/IEC Operation Process

  • GCP Audit & Issue Management

  • SOP Development & Management

  • Quality Risk Management in Clinical Trials – strategy, concept, methodology, process and implementation

  • Lead identification, escalation, investigation and resolution of quality/compliance issues

  • Leverage quality analytics data, internal and external factors and contextualized key quality insights to provide quality consultancy

  • Established quality oversight process for Patient Assistant Program

  • Conducted GCP audit at investigation sites and vendors in AP region

  • Conducted survey activities according to WHO “Surveying and Evaluating Ethical Review Practice” Guideline for ethics committee recognition in China, Thailand, South Korea, Philippine

  • Developed and implemented Human Research Protection Program

  • Trainer on standard course on “Research Ethics and Good Clinical Practice” and “Standard Operational Procedures of Ethics Committee”

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