Alessia Lucchetti

Background

About Alessia Lucchetti

Appointed as Associate Clinical Lead Director since October 2021, I act as a core project team member that partners with Project Leadership to ensure overall project meets delivery requirements. Previous role as Senior Clinical Lead from April 2016 to Sep 2021 and as Clinical Lead from August 2015 to March 2016. As a Ass. Clinical Lead Director my responsibilities include managing the operational aspects of projects to meet contractual requirements in accordance with SOPs, policies and practices; ensuring delivery of study quality and patient recruitment; driving site compliance; and leading, mentoring and training of the clinical operations team. I am managing the execution of the assigned clinical study per contract, from initiation through to closeout. I conduct frequent team and customer meetings. I provide project oversight of the clinical team, and I contribute and ensure implementation of the protocol, clinical monitoring plan, site monitoring materials, and training documents, as well as contribute to plans for data management/collection and drug accountability. I am also used to produce and distribute status reports for the Sponsor, core project team, other functional groups and senior management. I represents delivery with customer and I attend and lead Investigators Meetings, Kick-Off Meeting (KOM) and Bid Defence Meeting (BID). I am expert in various data systems (i.e. IRT, EDC-Inform/Oracle/iMedidata RAVE and other electronic study-systems) and competent with sites, eTMF and audits, as well as review and resolution of CAPAs. Experience in RBM and COVID-19 studies. Working in clinical research for over 15 years, I am experienced in various clinical settings, phase I - clinical trials. My experience, started as a CRA and went through different roles in these years: Clinical Research Specialist (CRS) acting as Clinical Team Leader (CTL) and Clinical Project Manager (CPM). I am experienced in the following therapeutic areas and indications: Internal Medicine (Infective disease - COVID-19), Gastro Intestinal (GERD, non-erosive GERD and Erosive Esophagitis in pediatric patients, Ulcerative Colitis in pediatric and adult patients, Chron's disease in pediatric and adult patients), Oncology (Polycythemia Vera, Chronic Lymphocytic Leukemia, Melanoma), Endocrinology (Diabetes Mellitus Type 2), Infectious disease (HIV), Respiratory (COPD), Psychiatry (Alcohol Dependence), Cardiovascular (Acute Coronary Syndrome and Atrial Fibrillation) and Internal Medicine (Women's infertility, Assisted Reproductive Technology treatment).