Clinical Operations Specialist

1 semana atrás

São Paulo, São Paulo, Brasil beBeeClinicalProjectManager Tempo inteiro R$55.000 - R$95.000
Job Description:

The Clinical Project Manager oversees the full scope of clinical trials from initiation to analysis phase, ensuring compliance with ICH guidelines and GCP regulations.

Responsibilities:
  1. Develop and execute comprehensive plans for assigned clinical trials in collaboration with senior team members.
  2. Set project goals and timelines, provide oversight, and foster a high-performing team to achieve results within defined parameters.
  3. Coordinate operational aspects of functional areas on assigned projects, ensuring adherence to regulatory requirements and trial procedures.
  4. Manage full-cycle clinical trial projects from start-up through analysis phase, overseeing team members and handling multiple projects simultaneously.
  5. Implement project activities according to the contracted scope.
  6. Organize, implement, and manage clinical trial projects, including development of trial plans and timelines.
  7. Participate in or oversee the creation of trial deliverables.
  8. Serve as primary point of contact for clients at the operational level.
  9. Oversee external vendors, review specifications, and ensure timely delivery and expectation fulfillment.
  10. Monitor project progress using computer-assisted tools, ensuring timely data entry and accurate reporting.
  11. Identify resource needs and communicate with department heads.
  12. Ensure effective training for the clinical trial team for protocol implementation.
  13. Oversee CRA tasks, site management, and data monitoring.
  14. Review and approve site reports, escalating issues as necessary.
  15. Attend site visits as required for observation or support.
  16. Manage project budget and scope, working closely with the Director for corrective actions and scope changes.
  17. Facilitate meetings for effective communication and decision-making.
  18. Prepare project status reports.
  19. Plan Investigator meetings and develop related materials.
  20. Maintain and audit the Trial Master File (TMF).
  21. Contribute to business development initiatives as requested.
Requirements:
  • Bachelor's degree or equivalent, preferably in a health-related field.
  • Minimum 3 years of research experience in clinical trials or related transferable skills.

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