Mario Xhani
Profilo professionale
Senior Clinical Study Coordinator & Trial Start-Up Specialist with 5+ years of experience in Phase I-IV clinical trials (oncology). Strong expertise in study start-up, site management, and budget/contract negotiation, with full involvement across the clinical trial lifecycle. Proven ability to coordinate cross-functional teams and act as key contact for Sponsors and CROs, ensuring data quality, regulatory compliance (ICH-GCP), and timely execution.
Panoramica
4
4
Languages
1
1
Certification
5
5
years of professional experience
Esperienza lavorativa
Senior Clinical Study Coordinator & Trial Start-Up Specialist
Humanitas Mirasole spa
Milan
2024.04 - 2026.07
- Manage Phase I-IV clinical trials in gynecologic oncology across full lifecycle
- Lead start-up activities: feasibility, CTIS submissions, site activation
- Coordinate study team and ensure timelines, compliance, and data quality
- Main point of contact for Sponsors/CROs (operational, regulatory, financial)
- Conduct budget and contract negotiation and support financial processes
- Oversee eCRF data entry/validation, query resolution, and SAE reconciliation
- Organize cross-functional meetings and support SOP development
Clinical Study Coordinator
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
2023.01 - 2024.03
- Supported Phase I-III trials in hematologic oncology (incl. CAR-T)
- Contributed to site start-up (ethics submissions, documentation, activation)
- Managed TMF/ISF and coordinated monitoring visits
- Collaborated with CRAs, Sponsors, and CROs
- Supported budget review and audit/inspection readiness
- Managed IMP accountability and IWRS/IRT systems
Clinical Study Coordinator Junior
AOU Careggi - University of Florence
2021.07 - 2022.12
- Supported conduct of Phase I-III trials in hematologic oncology
- Managed study documentation (ISF) and eCRF data entry/query resolution
- Supported pharmacovigilance (SAE/SUSAR)
- Coordinated monitoring visits, audits, and sample logistics
Junior Researcher (Internship)
Bracco
2021.02 - 2021.06
- Performed HPLC analysis and supported study documentation
Istruzione
Master (2nd level) - Drug Design & Synthesis
University of Siena
MSc - Medical & Pharmaceutical Biotechnology
University of Florence
BSc - Biotechnology
University of Florence
Competenze
- Study Start-Up & Site Activation (CTIS, EC submissions)
- Clinical Trial Management (Phase I-IV)
- Budget & Contract Negotiation
- eCRF & Data Management / Query Resolution and Data entry
- ICH-GCP & Regulatory Compliance
- Strong organizational and leadership skills
Language skills
Italiano, Albanese
Lingua madre
Inglese
Intermedio superiore
B2
Francese
Elementare
A2
Spagnolo
Elementare
A2
Risultati conseguiti
- Successfully initiated and activated over 50 multicenter, international, interventional clinical trials across Phases I–IV
- Significant contribution to obtaining IRCSS accreditation for Humanitas San Pio X.
- Significant contribution to obtaining ENGOT accreditation as a highly specialized hospital for gynecological cancers.
- Outstanding performance in audits and inspections, with zero observations reported.
- Development and leadership of a multidisciplinary team of eight professionals, including Study Coordinators, Data Entry Specialists, and a Trial Start-Up Specialist, with responsibility for coordinating and overseeing their activities.
Certificazioni
- GCP R3 Certification, Syneos Health, 07/01/25
- CTIS & EU Clinical Trial Regulation Training, AstraZeneca, 04/01/26
- Additional training in clinical research operations, data management, and regulatory compliance
Cronologia
Senior Clinical Study Coordinator & Trial Start-Up Specialist
Humanitas Mirasole spa
2024.04 - 2026.07
Clinical Study Coordinator
Fondazione IRCCS Istituto Nazionale dei Tumori
2023.01 - 2024.03
Clinical Study Coordinator Junior
AOU Careggi - University of Florence
2021.07 - 2022.12
Junior Researcher (Internship)
Bracco
2021.02 - 2021.06
Master (2nd level) - Drug Design & Synthesis
University of Siena
MSc - Medical & Pharmaceutical Biotechnology
University of Florence
BSc - Biotechnology
University of Florence