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Clinical Operations Specialist
hace 2 semanas
Major Accountabilities
~ Contribuye a todos los entregables de las pruebas operativas, de acuerdo con los plazos, el presupuesto, los procedimientos operativos, los estándares de calidad/cumplimiento y rendimiento.
~ Desarrollo de secciones específicas del protocolo y documentos conexos;
~ Desarrollo de herramientas de estudio, directrices y materiales de capacitación;
~ Implementación de planes de resolución de problemas;
~ Actuar como punto de contacto para todas las cuestiones relacionadas con el sitio y cuestiones de procedimiento;
~ Ayudar con las actividades a nivel de programa (por ejemplo, seguimiento de publicaciones relacionadas con el programa, desarrollo de secciones clínicas de documentos regulatorios, etc.)
~ Asegurar el manejo adecuado de todas las actividades de cierre del estudio, incluyendo pero no limitado al cierre del sitio, la rendición de cuentas final de los medicamentos y la preparación para la auditoría de la documentación del archivo maestro de prueba.
~ Responsable de la implementación de las mejores prácticas y estándares, incluyendo compartir las lecciones aprendidas.
~ Empresa interna frecuente y contactos externos. Puede representar a la organización en proyectos específicos
~ Notificación de quejas técnicas / eventos adversos / escenarios de casos especiales relacionados con los productos Novartis dentro de las 24 horas posteriores a la recepción
~ Distribución de muestras de comercialización (cuando proceda)
Key Performance Indicators
~ Contribuye, con la supervisión adecuada, a todos los aspectos de los ensayos clínicos globales para obtener resultados del estudio dentro del cronograma, el presupuesto, la calidad/cumplimiento y los estándares de rendimiento. Puede liderar aspectos específicos de los ensayos clínicos globales. Miembro principal del Equipo de Ensayos Clínicos.
Work Experience
~Experiencia multicultural
~Gestión y ejecución de operaciones
~Gestión de proyectos
Skills
~Monitoreo Clínico
~Investigación Clínica
~Informes de estudios clínicos
~Sistemas de Gestión de Ensayos Clínicos
~Ensayos clínicos
~Gestión de datos
~Orientado a los detalles
~Ciencias de la Salud
~Ciencias biológicas
~Gestión de proyectos
~Planificación de proyectos
~Habilidades de negociación
Language
Inglés
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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Division Operations
Business Unit CTS
Location Mexico
Site INSURGENTES
Company / Legal Entity MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.
Functional Area Research & Development
Job Type Full time
Employment Type Regular
Shift Work No
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