Francesco Azzollini
Clinical Project Manager @Novartis
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WORK HISTORY
Clinical Project Manager @Novartis
Milan, IT
The Clinical Project Manager (CPM) is a member of the Clinical Trial Team (CTT) and the Portfolio Team (PT), accountable for the day-to-day planning, executing and reporting,(from first site initiation visit to and including study site close-out), of assigned Global studies in assigned geographies in compliance with Novartis processes and regulatory requirements.The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies and countries. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies in all assigned countries. The CPM collaborates with the Country Manager, Country Head, Feasibility Manager, Study Start-up Manager and Site Partnership Manager and other local stakeholders in the planning, execution, and delivery of their assigned studies in assigned geographies. The CPM represents the voice of the cross-border community in assigned countries in the CTT. The CPM is accountable for execution and reporting of assigned Global studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM – CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.
EDUCATION
Università degli Studi di Milano-Bicocca
Master di II livello, Ricerca e sviluppo pre-clinico e clinico dei farmaci
Sapienza Università di Roma
Laurea Specialistica, Biotecnologie Mediche (indirizzo Bioingegneristico)
Liceo Scientifico - Tecnologico
Maturità, Liceo Scientifico-Tecnologico
Sapienza Università di Roma
Laurea Triennale, Biotecnologie
SKILLS
ABOUT FRANCESCO AZZOLLINI
Certified as Clinical Lead as per Clinical Lead Essentials IAOCR 5-star accredited Training Program (since Oct2020).Former Certified as Clinical Research Associate (until Dec2022).3 years of experience working as a Clinical Trial Manager, 8 years experience working as a CRA, 1 years experience working as a Site Start up Associate.In my current role, I serve as the clinical functional lead, accountable for the delivery of site management, clinical monitoring and central monitoring of assigned study(ies). I can independently manage the clinical and central monitoring team members but may serve as a regional clinical lead on larger trials under the direction of a Global CTM. I can provide leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to ensure compliance with the monitoring plan as well as ensure timeliness and quality of deliverables within the specified budget.I am a CRA Trainer since Jun2017 and a CRA Assessor since Sep2019, responsible to evaluate colleagues\' competencies to perform visits independently via Quality Evaluation Visits.I have deep experience in several therapeutic areas including- Oncology- Hematology- Infectivology- Diabetology- Neurology- Gastroenterology- Respiratory Diseases- Rare Diseases- Pediatrics- NeonatologyMoreover I have been working on different study phases (Ph I, II, have experience also in regulatory environment of Local Ethics Committees and Regulatory Authorities, as I have been dealing with submission process of clinical trials in Italy (from Initial Submission to Site/Trial Closure Notifications, including Critical Document Package approval and ICF customization).I am also experienced in Database Locks and Site Payments.I can ensures that the project deliverables are provided according to Company and/or Sponsor specifications, including delivery deadlines, and the Sites enrollment is boosted when needed.I have been working in both Multi-Sponsor and Single-Sponsor environments achieving severalaccomplishments during my carreer including, but not limited to, great performance during System Audit (with no findings) and winner of Sponsor Merit awards.As confirmed by his Clinical Operation Leads, I am very pro-active, with strong attention to details, cooperative, supportive, motivated, able to create excellent relationships with the Study Sites and the Study Team and, above all, extremely organized and flexible.
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