Valdine Medoh
Milan
Profilo professionale
Native in English and French, fluent in Italian (C2), with proven ability to work in international and multidisciplinary environments. Successfully supported sponsor audits with full compliance and no critical findings.
Panoramica
6
6
years of professional experience
1
1
Certification
Esperienza lavorativa
Clinical Research Coordinator / Data Manager
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
Milan
2024.01 - 2026.05
- Coordinate Phase II, III, and observational clinical trials in hematology, metabolic, and immunological disorders
- Act as primary liaison between Sponsor, CROs, Ethics Committees (IRB/IEC), and clinical site
- Support study start-up activities including submissions to Ethics Committees and budget discussions
- Manage Investigator Site File (ISF) and essential documents in compliance with ICH-GCP
- Ensure accurate and timely data entry in eCRF systems (Medidata RAVE)
- Track patient progress, schedule visits, and ensure protocol adherence
- Identify and report adverse events (AEs) and protocol deviations
- Prepare study status reports and support monitoring visits and audits
- Contributed to successful sponsor audit (May 2025) with no major findings
Research Intern (Preclinical)
Istituto Dermopatico dell’Immacolata
Rome
2020.10 - 2021.10
- Performed laboratory techniques including PCR, ELISA, Western Blot, and cell culture
- Conducted protein/DNA extraction and electrophoresis analysis
- Followed SOPs and Good Laboratory Practice (GLP) standards
- Presented experimental results and contributed to team discussions
Istruzione
Master’s Degree (Level II) - Preclinical and Clinical Drug Development: Scientific, Regulatory and Ethical Aspects
Università Cattolica del Sacro Cuore
Rome2023-01
Master’s Degree - Pharmaceutical Biotechnology
Sapienza University of Rome
2022-03
Competenze
- ICH-GCP Compliance
- Clinical Trial Coordination
- Study Start-up & Close-out
- ECRF / EDC (Medidata RAVE)
- Regulatory Submissions (IRB/IEC)
- Adverse Event Reporting
- Trial Master File (TMF) / ISF Management
- Patient Management & Visit Coordination
- Audit Readiness
Certificazioni
- ICH-GCP E6 (R3) – The Global Health Network
- IATA Certification – Mayo Clinic Laboratories
LANGUAGES
English: Native
French: Native
Italian: C2 (Fluent)
Disclaimer
Date, 10APR2026
signed
Cronologia
Clinical Research Coordinator / Data Manager
Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
2024.01 - 2026.05
Research Intern (Preclinical)
Istituto Dermopatico dell’Immacolata
2020.10 - 2021.10
Master’s Degree (Level II) - Preclinical and Clinical Drug Development: Scientific, Regulatory and Ethical Aspects
Università Cattolica del Sacro Cuore
Master’s Degree - Pharmaceutical Biotechnology
Sapienza University of Rome