Love Mondays


Vaga de Senior Site Manager (Monitor de Pesquisa Clínica Sr) – Janssen
Johnson & Johnson em São Paulo - SP

Descrição da Vaga

Senior Site Manager (Monitor de Pesquisa Clínica Sr) – Janssen - 7 positions

Descrição

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of
Companies, is recruiting for a Senior Site Manager (Monitor de Pesquisa
Clínica Sr). This position is located in São Paulo / Brazil.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters
most is helping people live full and healthy lives. We focus on treating,
curing and preventing some of the most devastating and complex diseases of our
time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical
solutions to address important unmet medical needs in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Please visit http://www.JanssenRnD.com for more
information.

The Senior Site Manager (Monitor de Pesquisa Clínica Sr) will be
responsible for site recruitment, patient recruitment and retention planning,
site initiation, monitoring and close-out. Ensure study related activities in
compliance with all Clinical Operations, Standard Operating Procedures (SOPs),
policies and regulatory requirements from Start-Up through Data-Base Lock.
Partner with trial team members to ensure overall site management while
performing trial related activities for assigned protocols. Serve as primary
point of contact and liaison between investigational site staff and study team
once site is initiated. Represent functional area(s) in divisional/company-
wide process initiatives.

Principal responsibilities will include:
- Participate in Site/Investigator feasibility, qualification and selection process by providing recommendations from local area.
- Execute activities within start-up, site monitoring, site management and site/study close-out, according to internal SOPs and policies.
- Write timely Visit Reports and submit via electronic Trial Master File (eTMF).
- Ensure site staff resolve data queries, and works with sites to ensure data timelines are met.
- Maintain accurate and timely data in systems utilized for clinical trial management (i.e. CTMS).
- Ensure timely and accurate data collection, documentation and communication of site/study progress and issues.
- Plan, conduct and document site staff training and monitors site performance.
- Present/participate in Investigator Meetings as needed.
- Monitor expiry date of Investigational Product and ensure study supply strategy is adequate.
- Mentor new hires with supervision and serve as Lead SM for a specific trial as needed.
- Review electronic Case Report Forms (eCRFs) and Completion Guidelines and participate in Electronic Data Capture (EDC) User Acceptance Testing (UAT) testing and special initiatives as needed.

Qualificações

  • A Bachelor’s degree in a Health or Science discipline is required. ****
  • Clinical research monitoring experience with any of the following Therapeutic Areas preferred: Oncology, Neuroscience, Immunology, Cardiovascular, Metabolics, Infectious Diseases, Vaccines.
  • Experience with Phase II and Phase III Clinical Trials required.
  • Knowledge of the drug development process, including Good Clinical Practices (GCPs), CEP/CONEP & ANVISA Regulations, is required.
  • Experience working with computer software applications is required.
  • Must have strong written and oral communication skills (Portuguese and English).
  • Willingness to travel is required.

We are an equal opportunity employer and value diversity at our company. We do
not discriminate on the basis of race, religion, color, national origin,
gender, sexual orientation, age, marital status, veteran status, or disability
status.

Leia mais

Avaliações da Johnson & Johnson


Satisfação geral dos funcionários

3.95
  • Remuneração e benefícios
    3.94
  • Oportunidade de carreira
    3.24
  • Cultura da empresa
    4.11
  • Qualidade de vida
    3.94

Recomendam a empresa a um amigo



  • Há 14 dias

    recomendo as vezes sim as vezes nao.

    Analista Júnior

    São Paulo, SP


    Prós: Bastante benefícios como desconto em produtos, um bom convenio médico com descontos em medicamentos e reembolso de consultas l, excelente restaurante, ambulatório de qualidade, salário na media do.mercado, plr, pagamentos em dia, emenda de feriados, home office e flexibilidade de horário, clima organizacional excelente, otima estrutura e organização em quesitos de limpeza.

    Contras: Como a empresa é muito grande seus processos são bastante complexos, quantidade enorme de processos faltando um pouco de organização entre as áreas. Muito trabalho para uma pessoa só. Baixo numero de funcionários para uma carga grande de trabalho, sobrecarregando aqueles que ja trabalham. Dificuldades em contratação e efetivação de terceiros e temporários. Necessitam atualizar a forma de gerenciar daqueles funcionários mais antigos e que são gestores.

    Recomenda a empresa: Sim

  • Há 16 dias

    Depende da área

    Analista de Recursos HumanosEx-funcionário, saiu em 2018

    São Paulo, SP


    Prós: Grande empresa com profissionais icônicos nas estruturas globais. Proporciona o reconhecimento profissional para funcionários que lidam bem com a politicagem interna.

    Contras: Clima ruim em algumas áreas da empresa. A área de Employee Relations não tem autonomia para tomar decisão sobre os casos que recebe, o que passa pouca credibilidade para os funcionários que abrem cases para averiguação de compliance. Diante disso, maus exemplos são fortalecidos dentro da estrutura e se passa a mensagem de Resultado a Qualquer Custo, independente do respeito com os demais.

    Conselhos para presidência: Valorizem os profissionais que vestem a camisa da empresa e dêem autonomia para a área de ERLR.

    Recomenda a empresa: Não