Clinical Research Scientist, Product Development
CurrentResponsible for clinical studies of AI software as medical device (SaMD) for early diagnosis of liver cancer (hepatocellular carcinoma, HCC):- Design of product based on clinical unmet need;- Development of protocols and case report forms (CRF) for clinical studies for FDA 510(k) submissions;- Management of publication development and research discussions with KOLs;- Analysis of clinical data and literature;- Collaboration with stakeholders, e.g., Regulatory Affairs, Radiologists, Data Managers, Statisticians, etc.