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Start for FreeElisangela Rorato
Clinical Project Manager @Aché Laboratórios Farmacêuticos
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WORK HISTORY
Clinical Project Manager @Aché Laboratórios Farmacêuticos
Guarulhos - SP, BR
Responsible for clinical research project management, including:\\\\n. Clinical trials in food, dermocosmetics and drugs in the following areas: diarrhea (phase I), vitiligo (phase II), dyslipidemia, endothelial dysfunction, epilepsy, adult and pediatric flu, rhinitis, low back pain, dermatophytosis (phase osteoarthritis (phase IV) and insomnia (phases II / Feasibility process (site evaluation, selection, negotiation and contract);\\\\n. Submission of ethical management (IRBs) and regulatory process (ANVISA);\\\\n. Blinding and logistics of the investigational product;\\\\n. Investigator\'s meeting;\\\\n. Recruitment strategies implementation;\\\\n. Budget planning and control;\\\\n. Negotiation, contracting, management and development of suppliers (CRO, electronic CRF, central laboratory, insurance, data management, biostatistics, courier);\\\\n. eTMF implementation;\\\\n. Risk and process mapping and management of the improvements implementation;\\\\n. Quality Management System implementation, including indicators (metrics) of quality and performance;\\\\n. Management team (8 people).\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
Fundação Vanzolini
Extensão, Capacitação em Gestão de Projetos
Fundação Vanzolini
Extensão, Capacitação em Gestão da Qualidade e de Processos
Universidade São Judas Tadeu
Graduação, Administração de Empresas
FGV - Fundação Getulio Vargas
MBA, Gestão Empresarial
ABOUT ELISANGELA RORATO
16 years of experience in project management in the pharmaceutical industry. I have been working in clinical development for 9 years as responsible for the management of in vivo and in vitro trials, which also include contracts, budget, recruitment, risk analysis, regulatory and logistics of clinical research with drugs (phase I - IV and pharmacokinetics), dermocosmetics, food and health products in Brazilian sites. Solid knowledge in Good Clinical Practice (GCP) ICH E6 (R2). In PMO, I managed for 7 years new product launch projects, covering all project phases and ensuring the effectiveness of all processes to achieve the objectives and goals of the organization. Ability to communicate and conduct negotiations with suppliers and external customers. Experience in mapping, process optimization and implementation of quality and performance KPI\'s. Mastery of the PMI methodology with practice in the management of all its knowledge areas. Use of MS Project tool and PPM (Project Portfolio Management). Team management skill.
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