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