Manager or Senior Manager, Clinical Quality Assurance

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.