Gabriella Gemelli
Clinical Data Manager @Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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WORK HISTORY
Clinical Data Manager @Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, IT
Managed clinical trial data import/export using Microsoft Excel for data review, cleaning and reporting.Developed and implemented Data Management Plans (DMPs) and Data Entry Guidelines. Updated Case Report Forms (CRFs) based on study protocols and clinical staff feedback. Ensured compliance with GCP and regulatory standards (EMA, FDA).Used electronic data capture systems (e.g. REDCap, TrakCare; Viewpoint, Digistat).Developed and maintained clinical registries for obstetrics patients to support departmental monitoring and analysis. Analyzed incidence trend across different Robson groups to support clinical evaluation and quality improvement initiatives. Developed aggregated datasets based on cesaren section rates and Robson classification to enable longitudinal and comparative analyses.Organized and participated in regular meetings with clinicians to identify reporting needs and adapt data collection tools accordingly.
EDUCATION
Università di Pavia
Master’s degree, Medical and Pharmaceutical Biotechnology
ZARA
Sales Assistant (part-time)
Imera School Center
Student representative
Fondazione IRCCS Istituto Neurologico Nazionale C. Mondino
Clinical Trial Internship, Stage
Clinical Research Lab
GCP and Clinical Research Training
Università degli Studi di Palermo
Bachelor's degree, Biotechnology
Università degli Studi di Palermo
Molecular Biology Training
ABOUT GABRIELLA GEMELLI
Currently serving as a Clinical Data Manager at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, contributing to clinical trial data management and ensuring compliance with GCP and regulatory guidelines. Responsibilities include managing data import/export, developing Data Management Plans (DMPs) and Case Report Forms (CRFs), and maintaining clinical registries for obstetrics patients to support monitoring and quality improvement initiatives. Holds a Master’s degree in Medical and Pharmaceutical Biotechnology from Università degli Studi di Pavia and completed a clinical trial internship at Fondazione IRCCS Istituto Neurologico Nazionale C. Mondino. Skilled in SOPs, data cleaning, quality control, and regulatory submissions, with certifications in ICH Good Clinical Practice (E6 R2). Motivated to advance in clinical research within CROs, pharmaceutical companies, or research institutions.
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