Serena Franciosi
Clinical Operation Manager @ITALFARMACO S.P.A.
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WORK HISTORY
Clinical Operation Manager @ITALFARMACO S.P.A.
EDUCATION
OPIS srl
Clinical Study Monitoring Professional Course
Università degli Studi di Milano
Dottore di Ricerca, Fisiologia
Università degli Studi di Milano
Laurea, Scienze Biologiche
ABOUT SERENA FRANCIOSI
CRA certified according to DM 31••••08.Over three years of experience in international studies of oncology, haemato-oncology and Neuroscience. Study at phase II and of SOPs/WPs, ICH-GCP and local regulations.Independent and proactive coordination of all activities required to set up and monitor a study:Responsible for-Feasibility studies-Site selection, initiation, monitoring and close out visits-Ensure timely submission of all documents for IEC approval-Prepararation of Essential Documents -Regulatory submissions-Study files management-Ensuring and maintain study timelines and achieving milestones-Ensuring the constant update of clinical research databases -Motivate investigators-Complete accurate status reports-Ensure the correct storage of drugs and accountability-Keep the project manager regularly informed-Process case record forms-Deal with Sponsor generated queries-Maintain patient and sponsor confidentiality-Assume additional responsibilities as required-Participate in mentoring new staff.Specialties: OncologyOnco-hematologyCardiologyPsychiatryVirology
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