Main Tasks:

• Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical trial/study.
• Assisting with preparation of protocols and other necessary documents required for trial approval by HA.
• Preparing protocols and other necessary documents required for trial approval by EC and getting EC approval on time.
• Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.
• Make monitoring plan, co-monitoring plan, budget and tracking plan and followed it during trial process.
• Tracking progress, status and performance regularly, find current problems/issues and make appropriate action plans.
• Coordinating and giving input to all activities including query resolution, site closure and collection of documentation required for c li nical trial reports after trail end.
• Ensuring but not li mited to, IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements.
• Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP
• Maintaining, updating and archiving all c li nical trial files on time.
• Maintaining up to date knowledge of diabetes treatment, company products, and cli nical trial conduction.
• Being LTM for CDP trial when needed, keep close contact with IO CDC or HQ project team.
• Being project leader when needed, coordinate and lead team members have regular project review meeting, ensure accuracy of meeting minutes.
• Coaching CRA from technical point.
• Any other responsibi li ties and duties which may be required from time to time.

Qualifications:

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