Oportunidades laborales


Puesto CRA II / Senior

JOB DESCRIPTION:

  • Perform site visits and monitor activities in accordance with protocol, GCP/ICH
    Guidelines, and applicable regulatory requirements, from SIV to SCV (phase I-IV)
  • Collaborate on procedures development, and query resolution.
  • Review and verify case report forms and other clinical data for completeness and
    accuracy.
  • Generate queries and manage resolutions with site staff.
  • Maintain project tracking systems as required.
  • Use expertise to identify and resolve complex site issues and deficiencies in
    documentation, communication, and the need for additional training.
  • Identify protocol deviations or major risks to data integrity.
  • Provide recommendations regarding site-specific actions.
  • Act as a liaison between the company and study site personnel and be able to
    respond to site concerns and questions.

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Puesto Clinical Trials Projects Manager

JOB DESCRIPTION:

  • Project Plan development and control
  • Project documents development (e.g.: Protocol, PIS, Investigator and Central Trial Master
    Files, etc.)
  • Start-up process management including finance and legal aspects.
  • Project control: documents, study procedures, IMP, monitoring and financing
  • Prepare projects documents for internal and external audits/inspections.
  • Generate, deliver and control project reports.
  • Collaboration in project data management.
  • Collaboration on scientific manuscripts edition and submission for publication

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