Clinical Affairs Specialist
Job ID :
50649BR
Location :
China - Beijing
:
Job Description
- To work for preparing and conducting IVD or other medical advice clinical trials which are needed by registration in China;
- Own for the trial preparation, such as protocol design;
- Own to conduct investigator selection, investigator meeting, and EC submission;
- To work for the clinical trial notification in local FDA;
- Track to meet target including source data verification, timeline, enrolled sample number etc.;
- Co-monitoring with CRA/CRC to ensure trial quality compliance with the requirement of GCP, SOPs and local regulations;
- Managing document filing according to the requirement of SOP;
- Execute the clinical trial plan to get the clinical report and other required document in a target timeline;
- Involve other clinical team work;
