Giorgia Donati
Trial Master File Specialist @Alfasigma
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WORK HISTORY
Trial Master File Specialist @Alfasigma
Pomezia, IT
EDUCATION
Università degli Studi della Tuscia
Abilitzione alla professione di biologo, Biología, general
Università Cattolica del Sacro Cuore
Corso di Master Universitario di 2° livello-CMU2, Sviluppo preclinico e clinico del farmaco: aspetti tecnico-scientifici, regolatori ed etici
Sapienza Università di Roma
Laurea Specialistica, Biotecnologie Genomiche
Università Cattolica del Sacro Cuore
Laurea triennale, Biotecnologie Sanitarie
ABOUT GIORGIA DONATI
Biotechnologist with solid experience in clinical research and document management, currently working as a Trial Master File Specialist at Alfasigma. I am responsible for the complete management of the eTMF, ensuring data quality, compliance, and inspection readiness in accordance with ICH-GCP guidelines and company SOPs.Over the past few years, I have gained strong expertise in Veeva Vault, contributing to the implementation and customization of the eTMF and CTMS modules. As a Clinical Business Administrator for both modules, I manage system maintenance and upgrades, support end users, and coordinate configuration changes according to business needs. I have also led several eTMF migration and transfer projects, from planning and execution to validation.I am passionate about digital transformation within Clinical Operations and believe that well-managed data and efficient systems are key to advancing the quality of clinical research.
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