Fabio Capone
Study Start-up Specialist @BeOne Medicines
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WORK HISTORY
Study Start-up Specialist @BeOne Medicines
Provide country-specific study start-up expertise, advising global teams on local requirements, timelines and risks.• Coordinate collection of essential documents from study sites and perform independent quality review and reconciliation of site files, preparing high-quality submission packages for Ethics Committees and Health Authorities in line with EU CTR and local regulations.• Track site performance and regulatory milestones, partnering with the Regional Clinical Operations Manager / Start-Up Lead and study sites to secure timely achievement of country start-up timelines and inspection-ready documentation.• Evaluate the quality and integrity of site practices, escalating quality/GCP issues to Investigators and internal teams and proposing corrective/preventive actions.• Anticipate and resolve site and country-level issues, challenging the status quo and contributing to process improvements and innovation in start-up activities (e.g. translation workflows, CTIS processes).
EDUCATION
Università di Pavia
Biennial Postgraduate Program, Regulatory Disciplines "G. Benzi"
Università Cattolica del Sacro Cuore
Postgraduate Course, Epidemiology and Biostatistics Applied to Clinical and Population Research
Università degli Studi di Napoli Federico II
Master’s Degree, Pharmacy
Liceo Ginnasio Statale "G. Garibaldi"
High School Diploma, Classics/Humanities
Università degli Studi di Milano
Postgraduate Specialization, Health Statistics and Epidemiology
ABOUT FABIO CAPONE
MSc Pharmacy graduate with a background in Pharmacoeconomics.• Experienced in site activation activities, ensuring clinical sites are ready to enroll patients and compliant with regulations, SOPs, and project requirements.• Proficient in navigating regulatory landscapes to facilitate clinical trials initiation.• Currently pursuing a Postgraduate Specialization in Medical Statistics and Biometrics to enhance clinical trials design expertise and project contributions.
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