Main responsibilities 1) Lead clincal study team to make clinical study protocol, conduct clinical study, and review clinical study report. Comply to CFDA regulation to ensure the product can launch on China market on timeline. 2) Make a plan and budget for clinical study projects. 3) Update clincial study SOP and management tools to ensure clinical study is conducted under good quality management system. 4) Input clinical study risk analysis during R&D project chart phase. 5) Monitor CFDA regulatory changes related with clinical study, and drive awareness and implementation of changed regulatory requirements.
Required work experience related to position At least three years experience of IVD clinical study . Excellent organizational, teamwork, problem solving, and communication skills. Bachelor degree or above in the biological / pharmaceutical sciences or Medical discipline.