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Clinical Trial Manager
hace 3 meses
Funciones y Responsabilidades**:
- Desarrollar y ejecutar exitosamente la gestión de los ensayos clínicos bajo su responsabilidad a nível local.
- Asegurar que el estudio se lleva a cabo en cumplimiento con las normativas locales y globales, GCP-ICH, SOPs aplicables, y en cumplimiento con el protocolo del ensayo.
- Supervisión de las actividades relacionadas con el ensayo y de los CRAs.
- Creación, gestión y supervisión del budget de los estudios bajo su responsabilidad.
- Desarrollar y ejecutar el Trial & Country Patient & Site Engagement Plan.
- Cumplimiento de las timelines y reclutamiento planificado.
- Establecer y mantener relaciones con los centros del estudio, asociaciones de pacientes y otros colaboradores externos e internos relacionados con el estudio y/o área terapéutica.
- Preparación para auditorías e inspecciones a nível local.
Perfil & Requisitos:
- Licenciatura en Ciencias de la Salud.
- Experiência previa mínima de 2 años en la industria farmacéutica gestionando ensayos clínicos.
- Conocimiento de regulación de ensayos clínicos y Buena Práctica Clínica (GCP).
- Habilidades de gestión de proyectos y organización.
- Habilidades de comunicación verbal y escrita en español e inglés.
- Capacidad de liderazgo, influencia y trabajo en equipo.
- Persona con foco en el paciente y en el investigador, entendiendo sus necesidades.
- Nível alto de inglés hablado y escrito. Mindset AAI.
Estamos continuamente trabajando porque queremos diseñar para ti la mejor experiência.
Estos son algunos ejemplos de cómo te cuidaremos:
- Horario flexible
- Seguro de vida y accidente
- Seguro médico a un precio competitivo
- Inversión en formación y desarrollo
- Cuidado de la salud
- Portal de ofertas para colaboradores Smartworking
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