1. Page 1/5 - Curriculum vitae of
Paola Meleo
Europass
Curriculum Vitae
Personal information
First name/ Surname Paola Meleo
Address Via Laurentina 1006b
00134 Rome - Italy
Telephone 0039 3381766464
E-mail paola.meleo@gmail.com
Nationality Italian
Date of birth June 29th, 1971
Work experience
Dates December 2010 - Present
Occupation or position held Senior Clinical Site Manager (aka Clinical Trial Manager)
Name and address of employer Bristol Myers Squibb srl – Rome - Italy
Type of business or sector Pharmaceutical Industry - Regional Clinical Operations
Main activities and responsibilities • Manages phase I, II III and IV clinical trials in compliance with ICH-GCP guidelines, internal SOPs
and local regulatory guidelines or regulations
• Manages and leads the study team (CRAs, Assistants, Regulatory, Data Management) across
different countries (Italy, Greece and Israel);
• Coordinates and maintains effective communication and serves as main contact for the whole team
assigned to the clinical trial;
• Coordinates initial and ongoing study training for study team and vendors, as applicable
• Provides feedback and status updates to internal stakeholders on an ongoing basis. Work closely with
other study team members in the coordination of study activities to meet the appropriate timelines at
the country/protocol level; participates as an active member of cross functional teams and keeps
management informed of project status in relation to quality, timelines and staff issues
• Leads the translation/review/approval of project related materials, including but not limited to
protocol/guidelines, informed consent forms, case report forms, site training materials, letters to
medical practitioners, reports, newsletters.
• Serves as main contact for a Contract Research Organization in case of outsourced studies;
• Provides ongoing training and mentoring to junior team members
• Responsible for editing the BMS Global Sample Informed consent and owner of the Italian Informed
consent sample with particular focus on Data Privacy;
• Member of the Audit and Inspection Team in charge for training BMS Regional Clinical Operation Staff
in case of Audits and Inspections.
• SEE GR & A Hub Specialist - South East Europe Global Recruitment and Analytics Hub Specialist,
who supports global connectivity of recruitment and retention efforts to enhance recruitment
performance for GDO clinical trials.
• RCO South East Europe SharePoint owner;
• Immunology Area Subject Expert, acts as consultant to provide input on the feasibility of study
conduction in Italy; counselling supporting STMs involved in applicable TA trials and HUM/Line
Manager in Country and sites selection; actively shares experiences and best practices through
coaching and feedback

2. Page 2/5 - Curriculum vitae of
Paola Meleo
Dates March 2005 – November 2010
Occupation or position held Clinical Site Manager (aka Clinical Trial Manager)
Name and address of employer Bristol Myers Squibb srl – Rome - Italy
Type of business or sector Pharmaceutical Industry – Regional Clinical Operations
Main activities and responsibilities • Coordinated study team of phase II-III-IV clinical trials (in Italy, Greece and Israel) in compliance with
ICH-GCP guidelines, internal SOPs and local regulatory guidelines or regulations
• Led study team (CRAs, Assistants, Regulatory, Data Management) and served as main contact for
the team assigned to the clinical trial;
• Conducted co-monitoring visits: pre-study, site initiation, site closure in phase II-III-IV trials in Italy
• Coordinated Site Monitors (CRAs) and reviews Monitoring Visit Reports for all sites in assigned
countries
• Collaborated closely with the Hub Manager and the Start up Specialist to perform site selection and to
monitor and supervise recruitment;
• Responsible for the review and approval of the clinical trials submission documents to CEC and LECs,
as applicable, in Italy, Greece and Israel.
Dates
Occupation or position held
Name and address of employer
Type of business or sector
Main activities and responsibilities
September 2003 – 31 July 2004 then 1 Sept 2004 until 1st March 2005
Clinical Site Manager (aka Clinical Trial Manager)
Bristol Myers Squibb srl – Rome – Italy
Pharmaceutical Industry – Medical Department
• Collaborated closely with CRO to supervise observational studies, compassionate use and phase IV
studies;
• Collaborates closely with legal dept. for contract negotiation;
Dates October 2001 – March 2003
Occupation or position held
Regulatory Affairs Assistant
Name and address of employer
Sigma-tau SpA - Pomezia (Rome) - Italy
Type of business or sector
Pharmaceutical Industry
Main activities and responsibilities
• In charge for the preparation of regulatory documentation for submission of phase I, II III and IV
clinical trials Competent Authorities;
• Responsible for entering clinical trials data in the “National Monitoring Centre for the Clinical Trials
(Osservatorio Nazionale sulle Sperimentazioni Cliniche dei Medicinali””) website linked to MoH;
Dates May 2000 – May 2001
Occupation or position held Visitor Researcher
Name and address of employer
University of Tennessee, USA
Department of Entomology and Plant Pathology,
Type of business or sector • Worked on a research program which sought to identify plant useful in biologically controlling
agriculture pests.
• Collaborated with the “Food Safety Center of Excellence” of the Veterinary School to perform
tassonomic identification of fungi

3. Page 3/5 - Curriculum vitae of
Paola Meleo
Education and training
Dates
Title of qualification awarded
Name and type of organisation
providing education and training
Principal subject/occupational
skills covered
April 2006 - 2 July 2016 (2 weekends per month)
Master in Pharmaceutical Management : marketing, market access and Sales
ISTUM: Istituto di Studi di Management
Marketing, Regulatory, Market Access and Sales
Dates January 1999 – January 2000
Title of qualification awarded Apprentiship post – lauream
Name and type of organisation
providing education and training
“La Sapienza” University - Rome, Italy.
Principal subjects/occupational
skills covered
Worked as laboratory Technician and also responsibilities for maintenance of fungal cultures and
bibliography research.
Dates
Title of qualification awarded
Name and type of organisation
providing education and training
Dates
Title of qualification awarded
Name and type of organisation
providing education and training
Dates
Title of qualification awarded
Name and type of organisation
providing education and training
Dates
Title of qualification awarded
Name and type of organisation
providing education and training
1990 – 1998
Degree in Biology (5 years degree )
University “La Sapienza” of Rome - Italy
1996 – 1997
Scholarship at the “Department of Animal and Human Biology”
University “La Sapienza” of Rome - Italy
1995 – 1996
Scholarship at the “Department of Animal and Human Biology”
University “La Sapienza” of Rome - Italy
1985 - 1990
High School Diploma
Liceo Scientifico E. Majorana – Rome - Italy
Personal skills and
competences
Mother tongue(s) Italian
Other language(s) English

4. Page 4/5 - Curriculum vitae of
Paola Meleo
Self-assessment Understanding Speaking Writing
Listening Reading Spoken interaction Spoken production
English fluent fluent fluent fluent fluent
Spanish very good very good good good fair
 TOEFL and GRE during my time spent in USA ;
 Business English Certificate Vantage – Cambridge ESOL
Socialskillsandcompetences Great ability to:
 adapt to a multicultural environment;
 work cooperatively with others in order to meet group and organizational goals;
 build and maintain strong relationships with team members, other functions, strategic
partners and customers;
 communicate opinions, facts and thoughts with clarity, transparency and honesty;
 enable and demonstrate the courage to speak up on issues and risks as well as on the
good news.
 seeks multiple perspectives and listens openly to others’ points of view;
Organisationalskillsand
competences
 capable of prioritize workload, great sense of organization;
 conscientious about meetings deadlines and completing tasks unsupervised;
 very good at supervising the work of support staff and coaching other team members;
 experienced at coordinating workgroups. Works productively both independently and in
teams, with experience working in international environment.
Technicalskillsand
competences
Excellent knowledge of:
 ECLIPSE: windows-based clinical study management system;
 IReview: client/server data review tool;
 eDM: oracle database management system for managing study design and clinical trials
data
 acquisition;
 SMT: for subject tracking, case report form tracking and metrics, discrepancy tracking and
metrics;
 CRF Imaging: for CRF submission tracking;
 ClinSight: a tool which gathers information used in monitoring activities;
 TAO: It’s a tool designed to collect clinical data electronically;
 ETMF: global repository for most study documents.
Computerskillsand
competences
Excellent knowledge of:
 Microsoft Windows environment (Windows 95, 98, 2000, XP, Vista);
 Microsoft Office package (Word, Excel, PowerPoint, Publisher);
 SharePoint;
 Image processing programs and graphic design applications: Adobe Photoshop,
 Adobe Illustrator.

5. Page 5/5 - Curriculum vitae of
Paola Meleo
Additional information
Scientific Publications
 Antifungal activity of monoterpenoids against Fusarium oxysporum - Meleo P., D. J. Trently
and K. D. Gwinn - Department of Entomology and Plant Pathology - University of Tennessee-
Poster presented at the meeting annual (26-29th August 2001) of American
Phytopathological Society in Salt Lake City, UT, USA. The abstract is in Phytopathology”
(supplement of July).
 Evaluation of antimicrobial agents for inhibiting fungal growth on agar media for isolation of
Campylobacter jejuni in cull dairy cow fecal samples - S. E. Murinda1, L. T. Nguyen1, S. J.
Ivey1, R.A.Almeida1, P.Meleo2 and S. P. Oliver1. 1Food Safety Center of Excellence,
2Department of Entomology and Plant Pathology - The University of Tennessee, Knoxville,
TN.
 Potential of Antimicrobial Agents to Inhibit Fungi to Aid Isolation of Campylobacter Shelton
E. Murinda, Lien T. Nguyen, Susan J. Headrick, Paola Meleo and Stephen P. Oliver
Foodborne Pathogens and Disease. September 2006, Vol. 3, No. 3: 309-314
CongressParticipation  Data Privacy Revolution - New European Regulation -20 April 2016 - Aboutpharma ;
 Seminar about Phase I Clinical Trials In Italy 30 March 2016 - “DETERMINA 29 marzo 2016
Autocertificazione dei requisiti minimi delle strutture sanitarie che eseguono sperimentazioni
cliniche di fase I ai sensi dell’articolo 3, commi 1 e 2 della determina 19 giugno 2015.
(Determina n. 451) - SIF and SFFA
 EULAR - The European League Against Rheumatism - The Annual European Congress of
Rheumatology on 2005 (Wien), 2006 (Amsterdam), 2008 (Paris), 2010 (Rome), 2015
(Rome);