CURRICULUM VITAE. Name: Florencia Licastro Job Title: Director, Training and Development. Summary of experience

Transcription

1 CURRICULUM VITAE Name: Florencia Licastro Job Title: Director, Training and Development Summary of experience Over 11 years working in Clinical Research in a large CRO, starting as Clinical Research Associate, Regional Clinical Team Leader and leading large global/multi-national studies across Latin America, Western Europe and USA. Later on she was appointed as Clinical Operations Manager and finally assuming the position of Manager of Clinical Project Management in the Oncology Unit. Experience working in infectious, respiratory, cardiology and oncology. Has also been involved with training and mentoring of staff in all instances related to Clinical Operations. Employment history Director, Training and Development / KLIXAR Reports to the Managing Director. Jun 2011 Present Responsible for training plans design. Responsible for the training of KLIXAR clinical team. Focal point for communication between sponsor and KLIXAR. Creation and review of SOPs. Manager, Clinical Project Management. Oncology Unit / Quintiles Argentina Jan 2011 May 2011 Reported to the Sr. Director, Clinical Project Management based in San Diego, California - USA. Managed a group of s based in Argentina, Brazil, Colombia, Peru, Chile and Mexico. Overall support and mentoring to Clinical s responsible for oncology trials. Resource management of Clinical s based in Latin America. Participation in bid defenses. Customer relationship. Clinical Operations Manager / Quintiles Argentina Jan 2008 Dec 2010 Reported to the Director, Clinical Operations. Managed a group of clinical monitors based in Argentina. Overall support and mentoring to direct reports involved in diverse projects. Support and mentor of clinical monitors involved in different trials. Resource management. Florencia Licastro Prado Version: Sep 2011 Page 1 of 5

2 / Quintiles Argentina Aug 2005 Dec 2007 Reported to the Associate Director, Clinical Operations. Management of project activities and project team members. Focal point for communication between sponsor and Quintiles. Responsible for managing, timelines, quality and costs of projects deliverables. Clinical Team Leader / Quintiles Argentina Jan 2003 Jul 2005 Reported to the Associate Director, Clinical Operations. Development and implementation of Clinical Management Plans for range of studies. Project set-up and planning. Management of the timelines and quality of deliverables. Management of clinical team. Tracking and management of the clinical budget. Clinical Research Associate / Quintiles Argentina Aug 2000 Dec 2002 Reported to a Line Manager, Clinical Operations. Study start up Monitoring Clinical trials Feasibilities CTL support Biochemist / Instituto de Cardiología y Cirugía Cardiovascular. Fundación Favaloro Aug 2000 Dec 2002 Reported to Lab Head. Haematology Service Biochemical Chemistry Service Internal Medicine Service Other related positions Project Management SOPs Task Force Member / Quintiles Argentina S.A. Jan 2010 May 2011 Production and review of Operating Procedures, Work Instructions, Templates and Approved Standard Forms for the Project Management Department. Also responsible for answering any queries regarding the interpretation and content of the controlled documents applicable to this functional area. People Soft Finance Champion / Quintiles Argentina S.A. Mar 2008 May 2011 Responsible for local trainings and for answering any queries regarding the use of the system, the localization of training materials and basic concepts of revenue, backlog and invoicing. Florencia Licastro Prado Version: Sep 2011 Page 2 of 5

3 Education Master in Business Administration Universidad del CEMA Buenos Aires, Argentina / Biochemist In progress Management and pharmaceutical marketing program Research Development Center Buenos Aires, Argentina (Post-graduate course) Fundación Campomar Buenos Aires University Buenos Aires, Argentina / Molecular Biology (Post-graduate course) and Advanced Biochemistry (Post-graduate course) 1999 School of Biochemistry - Moron University Buenos Aires, Argentina / Biochemist 1998 Language skills Spanish: Mother tongue English: Fluent French: Fluent Project experience Phase Indication Therapeutic area N Sites & III Hepatocellular Cancer / Oncology 180 sites retinoid 400 II Breast Cancer Oncology 60 sites 180 III Advanced Gastric Cancer Oncology 189 sites 700 III Osteoporosis / hormone Metabolism 170 sites 2600 III External Genital Warts / Green Tea Extract 50 sites 500 Role & Responsibilities November June 2007: Since study start up for Latin America (5 countries- 30 sites). Feasibility study only. Study cancelled. August December 2007: Since study start up for Chile and Mexico (10 sites) Regional CTL December 2004 June 2005: For Latin America (Argentina, Colombia, Chile, Brazil, Venezuela and Peru (40 sites) July December 2007: For Latin America (7 countries-45 sites) August 2002 January 2003:. Took over the study once patient recruitment ceased. Monitoring & site management for 1 site 250 subjects. Site audit by Quintiles. February 2002 October 2002: Start up activities Regional CTL January 2003 January 2004: For Latin America (Argentina, Colombia, Chile, Mexico Florencia Licastro Prado Version: Sep 2011 Page 3 of 5

4 Phase Indication Therapeutic area III Flu / Vaccine N Sites & 48 Sites-3200 Role & Responsibilities and Peru (38 sites, 375 ) Global CTL for Argentina, Colombia, Chile, Mexico, Peru, Rumania and US. ( 50 sites, 500 ) February 2002 September 2004: Monitoring & site management for 1 site 33 subjects. Full monitoring responsibilities. III Acute Myeloid Leukaemia / DNA Synthesis Inhibitor Oncology - January 2002 Feasibility study: 4 sites contacted III Invasive Candidiasis / Antifungal drug - January 2002 Feasibility study: 4 sites contacted III Lung Cancer Oncology - January 2002 Feasibility study: 2 sites contacted II Hepatitis B / Active Immunotherapy - January 2002 Feasibility study: 7 sites contacted II Gastroesophageal Reflux Gastrointestin al 18 sites 75 April 2001 October 2001: Start up activities and site selections for 4 sites II Congestive Heart Failure / diuretic III B Early Diagnosed Asthma / glucocorticosteroid Cardiovascular IV HIV / protease inhibitor 45 Sites-320 Respiratory 400 sites 7250 subjects 25 sites 220 February 2001 December 2001:. Monitoring & site management for 3 sites 38. Full monitoring responsibilities CTL support. August 2000 June 2003:. Took over the study once patient recruitment ceased. Monitoring & site management for 7 sites 236 subjects. Customer audit (office and 2 sites) August 2000 October 2001:. Monitoring & site management for 4 sites Other relevant experience - Audit Experience: Fully involved in audit responses and implementation of corrective action plans when applicable. 1 FDA audit 16 Sponsor audits 9 Quintiles contracted audits 2 internal audits Presentations in meetings: Clinical operations Quintiles Systems Kick Off Meeting. Hepatocellular cancer study February 15, 2007 Princeton, USA Florencia Licastro Prado Version: Sep 2011 Page 4 of 5

5 RECIST Criteria Investigator s Meeting, breast cancer study November 8, 2005 Panama, Ciudad de Panama GCP Training for Investigative Sites Training provided to clinical staff August 7, 2005 Cusco, Peru IVRS and Clinical supplies Jul 30, 2005 Buenos Aires, Argentina CRF and data Flow Jun 4, 2005 Cancun, Mexico IVRS and Clinical supplies May 21, 2005 Santiago de Chile, Chile Clinical Operations- Basics Pre- March 22, 2005 Buenos Aires, Argentina March 23, 2005 Santiago de Chile, Chile March 28, 2005 San Pablo, Brazil March 30, 2005 Lima, Peru April 1, 2005 Bogotá, Colombia Clinical operations CTL activities Kick Off Meeting. Gastric cancer study. February, 2005 New York, USA Lessons learn in studies Internal Closure meeting. study April 3, 2004 Barcelona, Spain. Lessons learnt training. Asthma study November, 2003 Singapore Data Management & Source documents Requirements Investigator s Meeting. External Genital Warts study Jun 4, 2003 San Diego, USA Florencia Licastro Prado Version: Sep 2011 Page 5 of 5