Clinical Research Medical Advisor

3 semanas atrás

São Paulo, São Paulo, Brasil Healthcare Businesswomen's Association Tempo inteiro

Job Description Summary

#LI-Hybrid
Supervisiona a execução e interpretação de pesquisas de ensaios clínicos, atividades de coleta de dados e operações clínicas. Estabelece e aprova métodos científicos para o desenho e implementação de protocolos clínicos, sistemas de coleta de dados e relatórios finais. Auxilia em pesquisas clínicas novas e contínuas e em ensaios clínicos, garantindo a eficiência e o processamento oportuno de acordos de confidencialidade e acordos clínicos. Supervisiona o cumprimento dos protocolos e determina a finalização dos estudos. Gerencia arquivos clínicos e regulatórios e mantém o inventário clínico previsto para distribuição aos locais de pesquisa. Pode interagir com locais de pesquisa, consultores clínicos, Organizações de Pesquisa Contratadas e outros fornecedores. Seleciona, desenvolve e avalia o pessoal para garantir o funcionamento eficiente da função.

Job Description

Key Responsibilities

  • Validar os desenhos dos estudos e avaliar a viabilidade dos ensaios com base na prática clínica e análise da concorrência.
  • Impulsionar o início rápido e de alta qualidade dos centros de pesquisa por meio de contribuições especializadas nas fases de planejamento.
  • Fornecer expertise clínica para interações com Comitês de Ética (IRB/EC) e conteúdo do termo de consentimento informado.
  • Desenvolver planos de estudo que abordem desafios de recrutamento e garantam a qualidade dos dados.
  • Oferecer treinamentos robustos sobre indicações, compostos e protocolos para stakeholders internos e externos.
  • Liderar estratégias de recrutamento clínico utilizando insights médicos e engajamento de pacientes.
  • Apoiar inspeções regulatórias e auditorias com conhecimento científico e clínico.
  • Garantir conformidade com padrões de segurança e fornecer parecer médico sobre eventos adversos.

Essential Requirements

  • Grau científico avançado (M.D. altamente preferido; Ph.D. ou Pharm.D. também considerados).
  • Forte compreensão dos processos de desenvolvimento clínico e diretrizes ICH/GCP.
  • Mínimo de 3 anos de experiência em desenvolvimento clínico ou prática clínica.
  • Capacidade comprovada de liderar equipes multifuncionais e resolver questões clínicas complexas.
  • Excelentes habilidades de comunicação em inglês e no idioma local.
  • Capacidade de realizar apresentações de alta qualidade e se adaptar a diferentes áreas terapêuticas.

Desirable Requirements

  • Treinamento em subespecialidade ou experiência com Evidência do Mundo Real (RWE).
  • Familiaridade com desenhos de estudo inovadores e fontes de dados como registros ou prontuários eletrônicos.

Skills Desired

Ciências da saúde, Clinical Monitoring, Clinical Trial Protocol, Conformidade regulatória, Decision Making Skills, Desenvolvimento de medicamentos, Ensaios clínicos, Lifesciences, Pesquisa clínica

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Lifesciences, Regulatory Compliance
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