Clinical Research Medical Advisor

Há 4 dias

Santo Amaro, Brasil Novartis Tempo inteiro

**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.

**About the Role**:
**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

Division

Development

Business Unit

Innovative Medicines

Location

Brazil

Site

Santo Amaro

Company / Legal Entity

BR03 (FCRS = BR003) NOVARTIS BIOCIENCIAS S.A

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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