Cta Submission Manager

hace 3 semanas


Barcelona, España Morgan Philips Group Sa A tiempo completo

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 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. Requisitos 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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