Clinical Trial Assistant Senior
- Location - Madrid
- Type of contract - 6 months – 6 months - Indefinite
- Salary - To be determined
- Experience - 5 years
- Languages - English B2 and Spanish
- Support for administrative procedures: request, follow up and final resolutions regarding approvals / authorizations of the initial submission of a study, as well as substantial modifications of Clinical Research, according to legislation and / or Applicable SOPs regarding CEICs, CEIm, AEMPS and CCAA, such as: telephone monitoring, quality control of documents, review of approvals, request for documentation, generation of traceability tables …
- REeC updating
- Preparation of the TMF, ISF and pharmacy file
- Preparation and supervision of the necessary forms for the implementation of the study, as well as the substantial modifications and notifications (Application Form Annex 1 A (Xml), Substantial Modification Form, Form 1D, etc.)
- Review and adaptation to the applicable law of general documents of the study
- Management of the necessary evaluation fees (request, invoice monitoring and payment management)
- Support for the preparation of the document of answers to the clarifications of CEICs, CEIm, AEMPS and CCAA, as well as the adaptation or implementation of changes requested in the essential documents of the study (eg HIP, questionnaires, patient card) in coordination with the team of the Department of Clinical Research or Department of Quality and Documentation assigned.
- Preparation of the transmittal form of the CRDs
- CTA course or experience in a similar position of at least 5 years
Responsable:
Sermes Planificación SLU
Finalidad:
Crear un punto de encuentro y conexión entre posibles empleados y la compañía, con el fin de ocupar vacantes laborales que puedan existir o estar abiertas.
Remitir una newsletter en caso de ser solicitada por el interesado.
Remitir una newsletter en caso de ser solicitada por el interesado.
Legitimación:
Consentimiento del interesado.
Destinatarios:
Sermes Consulting SLU
Derechos:
– Derecho a solicitar el acceso a los datos.
– Derecho a solicitar su rectificación o supresión.
– Derecho a solicitar la limitación de su tratamiento.
– Derecho a oponerse al tratamiento.
– Derecho a la portabilidad de los datos.
Información adicional:
Puede consultar la información adicional y detallada sobre Protección de Datos en nuestra página web.
Política de privacidad
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