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Clinical Trial Associate

4 semanas atrás

Santo Amaro, Bahia, Brasil Novartis Tempo inteiro
**Summary**:
Na Novartis, nosso compromisso é reimaginar a medicina. Como Associado de Ensaios Clínicos (CTA), você será peça-chave no suporte ao Gerente de Início de Estudos da SSO e ao Gerente de Projetos Clínicos da SSO nos estudos designados. Você contribuirá durante a configuração e todo o ciclo de vida do estudo, garantindo conformidade com os processos da Novartis, GCP/ICH e requisitos regulatórios.
**About the Role**:
**Principais responsabilidades da função**:
- Apoiar a coleta, preparação e adaptação de documentos para submissão ao IRB/EC e Autoridades de Saúde, conforme aplicável.
- Configurar sistemas.
- Apoiar a seleção de fornecedores, processo TPRM, entradas SIM.
- Gerenciar IF e TMF (TMF de país e site); configuração e manutenção de acordo com os requisitos regulatórios e da Novartis; supervisão e rastreamento de documentos.
- Apoiar a configuração de fornecedores, conforme aplicável.
- Verificar a completude do "Green Light" do site e garantir que toda a documentação esteja em ordem para a liberação inicial e subsequente de medicamentos em colaboração com a Pessoa Qualificada local.
- Apoiar a preparação e tradução do ICF para os idiomas locais (incluindo gestão de fornecedores, se necessário).
- Apoiar a preparação de material voltado para o paciente.
- Ser responsável pela completude dos documentos relacionados ao ensaio carregados no CREDI/SUBWAY, incluindo arquivamento de TMFs em papel.
- Apoiar a estratégia de SSU do país em estreita colaboração com o Líder de Equipe de SSU e Gerentes de SSU para garantir que os prazos e entregas de SSU sejam cumpridos de acordo com os compromissos do país.
- Garantir a adesão aos padrões financeiros, legislação vigente, ICH/GCP, IRB/IEC, Autoridade de Saúde e requisitos de SOP.
- Fornecer suporte logístico ao SSU CRA, CRA, CPM, Gerente de SSU em todas as fases do ensaio clínico.
- Implementar processos inovadores e eficientes que estão alinhados com a estratégia da Novartis.
**Requisitos essenciais para essa vaga**:
- Mais de 1 ano de experiência em operações clínicas.
- Compreensão do desenvolvimento de medicamentos clínicos, com ênfase particular na configuração de ensaios e contratação.
- Profundo conhecimento de MS Excel, MS Word, MS PowerPoint, idealmente conhecimento em SAP.
**Compromisso com a Diversidade e Inclusão**: A Novartis está empenhada em construir um ambiente de trabalho inclusivo e com equipes diversificadas que representem os pacientes e as comunidades que atendemos.
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