Speaker Information
Meet the speaker and learn more about their expertise, experience, and contribution to advancing clinical research.
Donatella Ballerini
Director, TMF Strategy,
VEEVA
With 20 years of experience in the pharma industry, Donatella Ballerini first gained expertise at Chiesi
Farmaceutici in the Global Clinical Development department, focusing on clinical studies in Rare Disease
and Neonatology. Later, in Global Rare Disease, Donatella served as a Document and Training Manager,
where she developed and implemented documentation management processes, leading the transition from
paper to eTMF. In 2020, she became the Head of the GCP Compliance and Clinical Trial Administration Unit
at Chiesi, ensuring all clinical operations processes complied with ICH-GCP standards and maintained
inspection readiness. In 2021, she joined Montrium as the Head of eTMF Services, where she helps
pharmaceutical companies in eTMF implementation and process improvement, and works as an
independent GCP consultant. In 2026, she joined Veeva as Director, TMF Strategy. In the last year, she also
handled some AI implementation projects, bringing her knowledge in risk and impact assessment: Member of
the CDISC TMF RM Education Governance Committee, the CDISC Risk White Paper Initiative, the CDISC
E3C Committee. Founder of the Italian TMF Community in 2025. Regular writer for the online Clinical Leader
newspaper and author of the eBooks �The Art of Sop�, �How to perform a TMF Document QC� and �The Real
meaning of TMF Quality Control�.
