Donatella Luciani

WORK HISTORY

EDUCATION

SKILLS

ABOUT DONATELLA LUCIANI

Clinical Trial & Operations Manager with 10+ years of experience in global clinical operations across CROs and pharma/biotech. Specialized in rare diseases, pediatric hematology, and advanced cell therapy — including CRISPR-Cas9 gene editing programs at European level.Throughout my career I have managed CRA teams, overseen multicenter studies from start-up to close-out, ensured GCP/ICH compliance and inspection readiness, and consistently delivered study milestones on time. I have worked in both full-service and sponsor-dedicated environments, and I thrive in roles requiring close collaboration with sites, cross-functional teams, and global stakeholders. Recognized with the Sponsor\'s Collaborative Award for outstanding contribution to team performance and study delivery. Alongside my core expertise in rare diseases and hematology, I have hands-on monitoring experience in neurology (migraine studies), scientific engagement with KOLs, and a strong interest in expanding my career into CTM or field-based clinical roles in these therapeutic areas. Currently seeking opportunities within a pharma/biotech sponsor — in rare diseases, hematology, or neurology — based in Italy or remote. Key areas: Rare Diseases · Hematology · Neurology · Gene Therapy · CRISPR-Cas9 · Cell Therapy · Clinical Trial Management · Clinical Trial Liaison · CRA Oversight · KOL Engagement · ICH-GCP E6(R3)