职位描述：
Area of responsibilities:
Main Tasks:
Duties and responsibilities which are subject to periodic updating include:
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 clinical trial reports after trail end.
Ensuring but not limited 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 clinical trial files on time.
Maintaining up to date knowledge of diabetes treatment, company products, and clinical 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 responsibilities and duties which may be required from time to time.
Supervision:
None
Main customers:
Internal customers:
All the internal colleagues in CRO, especially MED, MKT & Sales colleagues. The clinical operation colleagues in headquarters, IOCDC & other affiliates.
External customers:
All the healthcare professionals, officials. Especially the investigators in the clinical trials.
Education and Experience Requirements of the Position:
1.Bachelor's degree or above of Medical Science.
2.Rich working experience in conducting clinical trials.
3.Fluency English on both written & verbal.
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