- Recopilar, registrar y archivar información y documentos relacionados con el ensayo clínico de acuerdo con las Buenas Prácticas Clínicas (BPC).
- Apoyar en la preparación y mantenimiento de documentos del estudio, incluyendo protocolos, formularios de consentimiento informado, formularios de reporte de caso y presentaciones regulatorias.
- Coordinar reuniones de estudio y visitas a centros de investigación.
- Comunicación fluida con centros de investigación y proveedores del ensayo.
- Gestionar y procesar datos del ensayo clínico.
- Garantizar el cumplimiento de las normativas y las GCP.
- Brindar apoyo administrativo general al equipo de investigación clínica.
- Deseable formación universitaria.
- Mínimo de 4 año de experiencia administrativa en investigación clínica.
- Experiencia en submission.
- Excelente organización, atención al detalle y habilidades multitarea.
- Fuertes habilidades de comunicación escrita y verbal.
- Capacidad para trabajar de forma independiente y como parte de un equipo.
- Experiencia en TMF
- Software de oficina (Word, Excel, PowerPoint) a nivel usuario.
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CTA Submission Manager - Barcelona, España - Morgan Philips Executive Search
Descripción
Como CTA Manager, brindará apoyo administrativo y operativo vital a nuestro equipo de investigación clínica para garantizar la realización exitosa de ensayos clínicos. Trabajará en estrecha colaboración con el personal clave del estudio, como investigadores, coordinadores de investigación clínica y gerentes de proyectos, para garantizar el cumplimiento de las regulaciones y la precisión de los datos del ensayo.
Responsabilidades
Requisitos