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Especialista Senior en Puesta en Marcha de Estudios, IQVIA Biotech65258432104193120
Indeed
Especialista Senior en Puesta en Marcha de Estudios, IQVIA Biotech
Resumen: Esta función implica realizar actividades de activación de centros a nivel nacional conforme a la normativa vigente, los procedimientos operativos estándar (POE) y los requisitos del proyecto, actuando como punto único de contacto. Aspectos destacados: 1. Actuar como punto único de contacto para los centros investigadores y los equipos de proyectos. 2. Realizar actividades de puesta en marcha y activación de centros. 3. Garantizar el cumplimiento de los procedimientos operativos estándar (POE), las instrucciones de trabajo (IT), los entregables de calidad y los plazos del proyecto. Rawson, Argentina \| Jornada completa \| Teletrabajo \| R1505002**Oferta disponible también en otras ubicaciones** Descripción del puesto Realizar tareas a nivel nacional relacionadas con las actividades de activación de centros (AC), conforme a la normativa local y/o internacional aplicable, los procedimientos operativos estándar (POE), los requisitos del proyecto y las directrices contractuales/presupuestarias. También puede incluir actividades de mantenimiento. Funciones esenciales * Bajo supervisión general, actuar como punto único de contacto (PUC) en los estudios asignados para los centros investigadores, el gestor de activación de centros (GAC), el equipo de gestión de proyectos y otros departamentos según sea necesario. Garantizar el cumplimiento de los procedimientos operativos estándar (POE), las instrucciones de trabajo (IT), la calidad de los entregables designados y los plazos del proyecto. * Realizar actividades de puesta en marcha y activación de centros conforme a la normativa aplicable, los POE y las instrucciones de trabajo. Distribuir los documentos completados a los centros y a los miembros internos del equipo de proyecto. * Preparar los documentos reglamentarios del centro, revisándolos para garantizar su integridad y exactitud. * Asegurar la introducción y actualización precisas de la información específica del proyecto en los sistemas internos, bases de datos y herramientas de seguimiento. * Revisar y proporcionar retroalimentación a la dirección sobre los indicadores de desempeño del centro. * Revisar, establecer y acordar la planificación del proyecto y los plazos del mismo. Garantizar que se hayan implementado medidas de seguimiento y aplicar el plan de contingencia cuando sea necesario. * Informar a los miembros del equipo sobre la finalización de los documentos reglamentarios y contractuales correspondientes a cada centro. * Revisar, hacer un seguimiento y dar seguimiento al avance, aprobación y ejecución de los documentos reglamentarios, éticos, del formulario de consentimiento informado (FCI) y de los documentos relativos a la entrega del paquete del investigador (PI), en consonancia con los plazos del proyecto. * Brindar experiencia local a los GAC y al equipo de proyecto durante la planificación inicial y continua de los plazos del proyecto. * Realizar el control de calidad de los documentos facilitados por los centros. * Puede tener contacto directo con los patrocinadores en iniciativas específicas. Requisitos * Título universitario de licenciatura en ciencias de la vida o campo afín y 3 años de experiencia en investigación clínica u otra experiencia relevante; o combinación equivalente de formación, capacitación y experiencia. * 3 años de experiencia en investigación clínica, incluido 1 año de experiencia en un cargo de liderazgo. Combinación equivalente de formación, capacitación y experiencia. * Conocimientos profundos de los sistemas, procedimientos y estándares corporativos clínicos. * Buenas habilidades de negociación y comunicación, con capacidad para cuestionar, si procede. * Habilidades efectivas de comunicación, organización e interpersonales. * Capacidad para trabajar de forma independiente y priorizar eficazmente las tareas. * Capacidad para gestionar múltiples proyectos. * Conocimientos y capacidad para aplicar las Buenas Prácticas Clínicas (BPC)/Consenso Internacional sobre Armonización (CIH) y las directrices reglamentarias aplicables. * Conocimiento de los requisitos reglamentarios aplicables, incluidas las normativas locales, los POE y los estándares corporativos de la empresa. * Comprensión del entorno regulado de los ensayos clínicos y conocimiento del proceso de desarrollo de fármacos. * Capacidad para establecer y mantener relaciones de trabajo eficaces con compañeros, directivos y clientes. IQVIA es un proveedor global líder de servicios de investigación clínica, conocimientos comerciales e inteligencia sanitaria para los sectores de ciencias de la vida y atención sanitaria. Creamos conexiones inteligentes para acelerar el desarrollo y la comercialización de tratamientos médicos innovadores que ayuden a mejorar los resultados de los pacientes y la salud de la población a nivel mundial. Obtenga más información en https://jobs.iqvia.com IQVIA se compromete con la integridad en su proceso de contratación y mantiene una política de tolerancia cero frente al fraude cometido por candidatos. Toda la información y credenciales presentadas en su solicitud deben ser veraces y completas. Cualquier declaración falsa, tergiversación o omisión importante durante el proceso de reclutamiento dará lugar a la descalificación inmediata de su solicitud o a la terminación de su empleo, si se descubre posteriormente, de conformidad con la legislación aplicable. Agradecemos su honestidad y profesionalidad.
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