Chiara Martolini

Background

About Chiara Martolini

Clinical research professional Clinical and regulatory skills: Management of clinical studies with medical devices from start-up to close-out in different therapeutic areas. Preparation, review and completion of clinical submissions to Italian and other European national Ethics Committees and Competent Authorities, included communications on study progression, in compliance with EU Regulatory MDR 2017/745 and national regulations. Scientific overview of clinical studies from design to results dissemination. Relevant experience in analysis and interpreting of clinical data. Strong experience in studies with vulnerable population, i.e. minors with and without disability. Technical skills: Management of design, testing and validation processes for hardware and software solutions. Knowledge of the main regulatory related to medical devices. Technical documentation, including risk assessment. Experience in programming (Matlab, R, Python). Review and support in the preparation of technical documentation, e.g. Investigator Brochure, Clinical Study Report. Technical and educational background focused on medical devices in all the developmental phases, from design to commercialization. Communication skills: strong experience in working in cross-functional international teams, strong experience in communication with clinical sites and clinical sites personnel.