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Clinical Document Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeContent Tempo inteiro R$8.325 - R$10.736
Job Title:

Core Clinical Content Developer

">Job Summary:

We are seeking a skilled clinical content developer to join our team. The successful candidate will be responsible for developing, reviewing, and finalizing clinical trial documents.

Responsibilities:
  1. Develop informed consent forms and other clinical trial documents.
  2. Apply knowledge of GCP guidelines and regulatory requirements to review and develop ICFs.
  3. Ensure the content of the Master ICF aligns with the protocol and provides comprehensive information for potential research subjects.
  4. Ensure the consent form is understandable, clear, and complies with global industry standards.
  5. Include client-specific guidance during development and review of the Master ICF.
  6. Support the development, review, and approval of master templates for protocol/site activation.
  7. Create and revise training materials and plans for the team.
  8. Communicate timely and effectively with stakeholders regarding project trends, issues, safety concerns, and other relevant activities.
Requirements:
  • University/College Degree (medical degree preferred).
  • Minimum of 5 years experience in writing/editing clinical trial documents.
  • Advanced English skills (oral and written).
  • Strong knowledge of ICH-GCP guidelines and applicable regulations.
  • Relevant domain knowledge and experience may be considered for non-medical/life sciences backgrounds.
Additional Information:

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Engineering and Information Technology