Margarete Lopes

Margarete Lopes Email and Phone Number

State of São Paulo, Brazil
Margarete Lopes's Location
São Paulo, São Paulo, Brazil, Brazil
Margarete Lopes's Contact Details

Margarete Lopes work email

Margarete Lopes personal email

About Margarete Lopes

Professional with more than 15 years of clinical research experience as an executive and senior manager in International Pharmaceutical Industry and CROs.Leader in conducting Phase II, III and IV international studies and responsible for the management from protocol development through publication, including validation of Data Management, design review, training of sites and investigators with varying levels of experience.Leader of high performance and multiprofessional teams based in Brazil, Mexico and Argentina.Extensive experience in interface, empowerment and trainning of Medical Affairs team, Site staff and clinical research analysts.Extensive experience in developing projects set up ( team, financial forecast, sites feasibility and timelines). Main types of projects: Clinical, Interventional and Non-Interventional Studies, Investigator Initiated Studies, Expanded Access Program, Compassionate Use, and Post-Study Medication Programs.Coordination and operationalization of the Brazilian Scientific and Medical Information Service in a pharmaceutical company.

Margarete Lopes's Current Company Details
Nexial_Soluções em Pesquisa Clínica e Assuntos Científicos

Nexial_Soluções Em Pesquisa Clínica E Assuntos Científicos

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Consultor e Assessor Independente
State of São Paulo, Brazil
Employees:
4
Margarete Lopes Work Experience Details
  • Nexial_Soluções Em Pesquisa Clínica E Assuntos Científicos
    Consultor E Assessor Independente
    Nexial_Soluções Em Pesquisa Clínica E Assuntos Científicos
    State Of São Paulo, Brazil
  • Nexial _Solutions In Clinical Research
    Advisor And Consultant Clinical Research Activities/Clinical Project Manager/Quality And Excellence
    Nexial _Solutions In Clinical Research Mar 2019 - Present
    Sao Paulo
    Multidisciplinary teams training in: clinical reserch concepts, studies conductions, responsabilities, good practices in documentation and archieve, regulations, pharmacovigilance, scientific publications and access programs.Training, qualification and optimization of clinical research sites.Conducting of all Co-monitoring activities (virtual or live).Improving partnership between clinical research sites, investigators and sponsors.Development of risk management plans to identify and track mitigation actions.Development, implementation and monitoring of Key Performance Indicators.Leadership, coordination and development of process improvement initiatives, SOPs lifecycle, manuals or guides.Establish and maintain internal operations excellence governance strategy(company-wise), including the assessment of new technology/partnerships.Development of processes for identifying, feasibility and qualification of clinical research sites for effective participation in clinical research studies.
  • Clinergy Health Research
    Clinical Excellence & Compliance Lead (Ce&Cl)
    Clinergy Health Research Jul 2021 - Present
    São Paulo, São Paulo, Brasil
  • Ipsen
    Medical Project Manager
    Ipsen Aug 2019 - Feb 2021
    Sao Paulo
  • The Janssen Pharmaceutical Companies Of Johnson & Johnson
    Associate Director - Global Trial Manager - Global Clinical And Development Operations
    The Janssen Pharmaceutical Companies Of Johnson & Johnson Jan 2007 - Nov 2018
    Brazil
    Feb 2016 to Nov 2018: Associate Director and Global Trial Manager in Global Clinical Development Operations (GCDO) Medical Affairs Operation (MAO) in Latin America, JanssenRegional Operational Lead for Initiated Investigator Studies and Collaboratives studies in Latin America, Janssen – J&JJul 2012 – Jan 2016: Functional Manager for Multiprofessional clinical research teams in Latin America, Janssen – J&J (Brazil, Mexico and Argentina)Jan 2008 - Jul 2012: Clinical Research Manager, Local Medical Affairs Department, Janssen Brazil –J&JFeb 2007 – Jan 2008: Senior Clinical Research Analyst, Janssen, Sao Paulo, Brazil
  • Vigiun Ltda
    Cra
    Vigiun Ltda Apr 2002 - Dec 2006
    São Paulo, São Paulo
    Clinical Research Analyst, VIGIUN – Pesquisa Clínica e Epidemiológica, Brazil
  • Universidade Federal Do Rio De Janeiro
    Registered Nurse
    Universidade Federal Do Rio De Janeiro Jul 1989 - Dec 1994
    Hospital Clementino Fraga - Ufrj - Rio De Janeiro
    Head of nursing team responsible for oncology, renal transplant, cardiology and nephrology patients

Margarete Lopes Skills

Clinical Trials Management Strategic Planning Pharmaceutical Industry Pharmacovigilance Clinical Development Gcp Regulatory Affairs Team Leadership Clinical Research Oncology Good Clinical Practice Pop Oncologia Treinamento E Desenvolvimento

Margarete Lopes Education Details

Frequently Asked Questions about Margarete Lopes

What company does Margarete Lopes work for?

Margarete Lopes works for Nexial_soluções Em Pesquisa Clínica E Assuntos Científicos

What is Margarete Lopes's role at the current company?

Margarete Lopes's current role is Consultor e Assessor Independente.

What is Margarete Lopes's email address?

Margarete Lopes's email address is lo****@****ail.com

What schools did Margarete Lopes attend?

Margarete Lopes attended Fundação Getulio Vargas, Universidade Do Estado Do Rio De Janeiro, Universidade Federal Do Rio De Janeiro.

What skills is Margarete Lopes known for?

Margarete Lopes has skills like Clinical Trials, Management, Strategic Planning, Pharmaceutical Industry, Pharmacovigilance, Clinical Development, Gcp, Regulatory Affairs, Team Leadership, Clinical Research, Oncology, Good Clinical Practice.

Who are Margarete Lopes's colleagues?

Margarete Lopes's colleagues are Lívia Gomes, Naveen Kumar, Duane Tyrone, Thais Silviano Cardoso, Daniele Aguiar, Rucha Majmundar Mehta (Mrqa) Fcn, Kelly Proença.

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