Luana Ferlito
Summary
I am a Clinical Trial Manager passionate about clinical research and proud to make my contribute to the health of global society. My mission in clinical research is patient centricity and ensuring the highest quality and efficiency of clinical studies in compliance with ethical and regulatory standards. Day by day my key words are value, empowerment, inclusion, and diversity, to create a tender environment in which all colleagues feel safe and free to express themselves. Good leadership, coordination of team and communication skills even in multicultural contests. I care about people, I love working in a team, supporting and inspiring colleagues, making them more confident and motivated to achieve the common goal together. Strong aptitude for managing more studies at the same time, analytical/problem-solving skills, cross-functional collaboration. I am a curious person who cares about developing skills through mentorship programs.
Overview
13
13
years of professional experience
Work History
Global Clinical Project Manager Consultant
Pharmacos on behalf of Bioprojet Pharma
06.2024 - 08.2024
- Global Management of a pilot phase III clinical trial in neurology
- Project preparation: protocol writing, study key documents development and validation with the medical director
- Data management plan redaction
- Define the global study team activities and study timelines, ensuring deliverables within budget
- Suppliers/CRO selection and contract negotiations oversight
- Establish the start-up and enrollment strategy
- Oversee study submissions, support and guide the study team to ensure comfort with workload
- CTMS-like system set-up and management
- Provide direction for TMF management
- Budgeting
Clinical Trial Manager
Boehringer Ingelheim
05.2022 - 06.2024
- Leading global clinical trials from phase I to IV across diverse therapeutic areas such as oncology, cardiometabolic, respiratory, and rare diseases
- Overseeing clinical trial operations from start to finish, ensuring adherence to ICH-GCPs and relevant regulations, while achieving project goals within timelines, quality standards, and budget constraints
- Responsible for protocol and site feasibility evaluations, and final site selection with cross-functional teams
- Managed local enrollment strategy and execution from allocation to LPLV
- Organize trial training sessions per the Trial Training Plan
- Ensure all team members are prepared and understand the study's goals
- Conduct regular meetings for open communication and feedback
- Building and maintaining strong partnerships with CROs is crucial
- Continuously assess their performance and suggest improvements to enhance service quality
- Use CTPMs to track clinical trial performance metrics (KPI) and evaluate trial efficiency and effectiveness
- Develop tools and processes
- Proficient in various project management tools and methodologies, including Critical Chain, ProChain Enterprise, MS Project, etc
- Conduct risk assessments to identify risks and develop mitigation plans
- Ensure action plans resolve issues and enhance processes
- Implement CAPA plans
- Ensure timely data entry, database lock, and monitoring in accordance with TLMM
- Budget management
- Engage in international projects, embracing cultural diversity and showcasing motivational abilities
- Create and propose innovative strategies for engaging sites and patients globally
- Manage European study submissions in line with Regulation (EU) No
- 536/2014, overseeing start-up processes and contract negotiations
- Ensure timely and compliant document archiving and manage the eTMF
- Set-up the site and patient engagement plan
- Collect feedback from investigators and patient associations to enhance study design and improve the patient journey
Clinical Project Manager in Hematology
Istituto Clinico Humanitas - Cancer Center
08.2019 - 05.2022
- Management of onco-hematological phase I-III clinical trials and Observational Studies (lymphomas, myelomas, GVHDs, leukemias) following ICH guidelines for GCP
- Development of clinical trials sponsored by Humanitas Research Hospital: protocol writing, CRF design, budgeting, and stakeholder selection
- Overseeing the study team, facilitating training sessions, and fostering team cohesion and communication
- Set-up and manage CTPM-like systems
Case Reports Forms Consultant
Merck Healthcare KGaA
08.2019 - 09.2019
Clinical Study Coordinator in Oncology
Istituto Clinico Humanitas - Cancer Center
04.2016 - 06.2019
- Coordination of clinical trials for lung cancer, covering Phases I, II, and III, within the Lung Cancer Division, from start to finish
- Overseeing the management of eCRF and IWRS systems
- Supervising drug monitoring, including ADRs reporting, SAE/SUSAR collection, and distribution
- Ensuring data forms are accurate, legible, and complete; conducting early risk assessments, implementing CAPA, and performing root cause analysis for any protocol deviations
- Manage the coordination and administrative responsibilities of clinical trials, supporting physicians and clinical nursing staff in carrying out procedures as specified by the study protocol
- I inspire enthusiasm and empower team members
- Guiding team collaboration through weekly meetings to evaluate studies, deliberate on clinical cases, tackle issues, and formulate solutions
- Assist CRAs during monitoring visits and guide the study team in audit preparation
Clinical Study Coordinator
European Institute of Oncology (IEO)
01.2015 - 01.2016
- Management of phase I and IIa clinical trials as part of Division of New Drugs and Early Drug Development for Innovative Therapies
Pharmacist
Admenta Italia S.p.A. - Farmacia Comunale Centrale
01.2013 - 01.2014
Pharmaceutical Intern (Erasmus Placement)
Pharmacie des Rosiers
06.2011 - 09.2011
Education
II level Master's degree - Biostatistics and Epidemiological Methodology
University of Pavia
02.2021
Educational Training - Clinical Project Management
Clinical Research Educational Services Srl - CRES
05.2020
Master's degree - Preclinical and clinical drug development: scientific, regulatory and ethic aspects
Università Cattolica del Sacro Cuore di Gesù (UCSC)
12.2015
Master's degree - Pharmaceutical Chemistry and Technologies
Alma Mater Studiorum - University of Bologne
10.2014
Skills
- Project Management
- Synopsis Writing
- Data interpretation
- Risk analysis
- Budgeting
- Team management
- Result-oriented
- Analytical
- Team player
Timeline
Global Clinical Project Manager Consultant
Pharmacos on behalf of Bioprojet Pharma
06.2024 - 08.2024
Clinical Trial Manager
Boehringer Ingelheim
05.2022 - 06.2024
Clinical Project Manager in Hematology
Istituto Clinico Humanitas - Cancer Center
08.2019 - 05.2022
Case Reports Forms Consultant
Merck Healthcare KGaA
08.2019 - 09.2019
Clinical Study Coordinator in Oncology
Istituto Clinico Humanitas - Cancer Center
04.2016 - 06.2019
Clinical Study Coordinator
European Institute of Oncology (IEO)
01.2015 - 01.2016
Pharmacist
Admenta Italia S.p.A. - Farmacia Comunale Centrale
01.2013 - 01.2014
Pharmaceutical Intern (Erasmus Placement)
Pharmacie des Rosiers
06.2011 - 09.2011
Educational Training - Clinical Project Management
Clinical Research Educational Services Srl - CRES
Master's degree - Preclinical and clinical drug development: scientific, regulatory and ethic aspects
Università Cattolica del Sacro Cuore di Gesù (UCSC)
Master's degree - Pharmaceutical Chemistry and Technologies
Alma Mater Studiorum - University of Bologne
II level Master's degree - Biostatistics and Epidemiological Methodology
University of Pavia
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