Start Up Specialist
hace 4 semanas
Study Start Up Specialist (Regulatorio de Estudios Clínicos) page is loaded
Study Start Up Specialist (Regulatorio de Estudios Clínicos)
Apply locations Lima time type Full time posted on Posted Yesterday time left to apply End Date: November 19, 2024 (4 days left to apply) job requisition id 202410-126705
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position
Un futuro más saludable. Es lo que nos impulsa a innovar. Avanzar continuamente en la ciencia y garantizar que todos tengan acceso a la atención médica que necesitan hoy y en las generaciones futuras.
Crear un mundo en el que todos tengamos más tiempo con las personas que amamos.
Eso es lo que nos hace ser Roche.
Oportunidad
El Start Up Specialsit c ontribuye de manera crucial al proceso de reclutamiento de pacientes y a la evaluación de la viabilidad de estudios clínicos en diversas áreas terapéuticas. Diseña cuestionarios detallados de viabilidad enfocados en los objetivos de cada estudio y elabora informes exhaustivos basados en las evaluaciones realizadas. Lleva a cabo búsquedas meticulosas para identificar los sitios más prometedores para los estudios clínicos. Además, desarrolla estrategias innovadoras y materiales atractivos para el reclutamiento eficaz de pacientes
- Cumplimiento Regulatorio: Actualiza el conocimiento sobre requisitos regulatorios y garantiza el cumplimiento de regulaciones locales y procedimientos internos.
- Actividades de Inicio de Estudios: Ejecuta todas las actividades preliminares antes de la activación de los centros en estudios asignados, conforme a los estándares de Roche y los requisitos del proyecto.
- Documentación Regulatoria y Ética: Prepara y obtiene aprobaciones para la Forma de Consentimiento Informado y gestiona modificaciones y notificaciones para comités de ética y autoridades regulatorias.
- Análisis de Datos y Mejora Continua: Conserva y analiza datos iniciales del estudio para optimizar plazos de inicio y propone mejoras continuas.
- Negociación y Colaboración en Estudios: Negocia presupuestos y contratos del estudio, y colabora en la identificación y monitoreo de nuevos centros de investigación, así como en estrategias de reclutamiento y retención de pacientes.
Quien eres
- Grado universitario o equivalente en campos relacionados con la ciencia/medicina.
- Ingles avanzado, tanto verbal como escrito.
- 2 años de experiencia en el campo de estudios clinicos.
- Conocimiento de estudios clínicos y experiencia en gestión de proyectos.
- Conocimiento de la Conferencia Internacional de Armonización de requisitos técnicos para productos farmacéuticos para uso en humanos, Buenas Prácticas Clínicas (ICH-BPC), así como comprensión de los requisitos regulatorios, éticos y contractuales para iniciar estudios clínicos en el país relevante.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
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