Clinical Quality Support & Training Manager

Major Responsibilities：

• Familiar with ICH GCP, China GCP and company’s SOPs.
• Conduct GCP/SOP compliance check for local phase IV trials. Maintain and follow up action plan.
• Work as clinical trial quality responsible person to be involved in CQA audit conducted by HQ and help to complete action plan.
• Perform co-monitoring activities to key ongoing studies, including CDP and Local trials.
• Provide training and support for clinical related systems, such as EDC, IMPACT, e-clinical etc.
• Involve in SOP review procedure, and give comments accordingly.
• Comparing with QBIQ SOPs, make gap analysis for Local SOPs.
• Draft and update Local SOPs.
• Set up SOP matrix and update it timely.
• Organize SOP training workshop, maintain group training records.
• Work as training contact person in CRO to collect training needs and give feedback to IOCDC.
• Work as CQS team member to take part in the CQS team activities as per required.
• Provide GCP/SOP training to new CRAs.
• Provide technical supports to clinical trial team members, when needed.
• Provide GCP training to external customer, as paer required.

Requirement：

• Bachelor’s degree or above of Medical Science.
• Rich working experience in conducting clinical trials.
• Working experience in quality area.
• Fluency English on both written & verbal.