- O/a Gerente de Pesquisa Clínica (CTM) é responsável pela gerenciamento, planejamento, implementação e conduçao dos estudos clínicos no Brasil e Latam (Argentina, Chile, Colombia, Peru e México);
- O/a CTM é a peça principal do desenvolvimento do estudo clínico no pais, garantindo agilidade na implementação, no recrutamento e finalização, além da qualidade dos dados e segurança dos participantes;
- O/a CTM é um membro proativo da equipe do estudo, e trabalha em estreita colaboraçao com o CTL (lider global do estudo), com as equipes locais de cada país, além da CRO e centros de pesquisa;
- O/a CTM tem uma função primordial para que o pipeline seja desenvolvido de maneira rápida e para que a Boehringer continue a transformar vidas por gerações
- Conduzir e entregar os estudos clínicos conforme protocolo do estudo, dentro dos timelines previstos e em cumprimento com o budget, os SOPs, ICH-GCP e todas as demais regulamentacoes externas;
- Trabalhar em parceria com os times locais/regionais, com as CROs e com os centros de estudo visando a preparação adequada e em tempo dos documentos do estudos, dos contratos e a obtenção das aprovações necessárias, bem como o atingimento do recrutamento proposto para o país/países da Latam;
- Interagir com os times locais para garantir que os requerimentos regulatórios locais sejam cumpridos;
- Garantir que as equipes internas e externas (CROs e centros de estudo) estejam treinados no que diz respeito a treinamentos estudoespecíficos;
- Garantir que os documentos do estudo estejam arquivados no eTMF;
- Supervisão do budget dos estudos.
- Formação Acadêmica Completa em áreas de saúde;
- Experiência com projetos de pesquisa clínica;
- Experiência com Analytics;
- Experiência com gestão de projetos estratégicos;
- Inglês Avançado;
- MBA
- Desejável.
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Clinical Trial Manager - São Paulo, Brasil - Bi Do Brasil Quim E Farm Ltda
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Usuários da profissão Clinical Trial Manager em São Paulo
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Ursula Maschette
Psicóloga especialista em saúde mental reprodutiva