Manager or Senior Manager, Clinical Quality Assurance

Beijing, Guangzhou, Shanghai
Posted 3 years ago

Main Responsibilities:

  • Accelerate the improvement of study quality by implementing Quality Assurance (QA) activities and driving quality initiatives, manage the quality risk of clinical studies in compliance with ICH-GCP, Chinese GCP, other related Chinese regulations, study related Standard Operation Procedures (SOP) of the company and study protocol
  • Support QA head to set up and maintain clinical quality management system, including study related SOPs at company level and electronic systems according to regulations
  • Carry out study audit, and support study teams and clinical QC personnel on inspection
  • Maintains current knowledge and understanding of regulations and industry practices in relation to clinical studies
  • Close collaboration with cross-functional stakeholders to track new or changes in local regulations or process

Minimum Requirements:

  • Bachelor degree or above in medical science or related field;
    Desirable: medical/pharmacological background
  • At least 2 years proven project management experience in clinical study
  • At least 2 years as Clinical Process Manager or equivalent
  • 2 years proven training or coaching experience
  • Good understanding of knowledge and skills required for the successful delivery of a clinical study, e.g. ICH-GCP, Chinese GCP, other study related regulations, study management, site management, monitoring
  • Understands the regulatory environments and the drug development process.


Clinical Development

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