Senior Clinical Trial Monitor

hace 2 semanas

México Bristol-Myers Squibb A tiempo completo

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.**

Responsable de la supervisión del progreso de un ensayo clínico y de garantizar que se realice, registre e informe de acuerdo con el protocolo, los procedimientos operativos estándar (SOP), las buenas prácticas clínicas (BPC) y los requisitos reglamentarios aplicables ( s).

Actuar como uno de los puntos de contacto a nível de Hub para las partes interesadas internas y externas.
- Contribuir significativamente al equipo de estudio y al personal del sitio de entrenadores para mejorar el rendimiento del sitio y del centro.
- Servir como un recurso clave para los colegas, proporcionando orientación, capacitación líder y tutoría a otros miembros del equipo a través de un proceso de tutoría mediante presentaciones formales e informales.
- Ayudar a la gerencia en diversas tareas, según se le asigne o solicite.

Busque de manera proactiva mejorar las habilidades de comunicación tanto con las partes internas (nível global) como con todas las partes externas relevantes y entrene a otros para que hagan lo mismo.
- Identifica nuevos investigadores potenciales, a través de colaboraciones continuas con partes interesadas internas y externas. Evalúa investigadores potenciales y sus sitios para asegurarse de que tengan los recursos y las capacidades para realizar ensayos clínicos. Documenta la visita y comunica los hallazgos. Proporciona comentarios sobre los hallazgos de la Evaluación potencial del sitio a los colaboradores. Recomienda sitios durante el proceso de viabilidad y / o selección del sitio.
- Desarrolla nuevos sitios, que tienen una experiência mínima en investigación, brindando apoyo para comprender los requisitos para ejecutar ensayos clínicos (es decir, SOP, capacitación, recursos de personal, etc.)
- Determina la necesidad y / o el tipo de visita previa al estudio que se requiere según la experiência previa del sitio con la ejecución de ensayos clínicos de BMS.
- Realiza visitas de iniciación en colaboración con otros miembros del equipo de estudio y grupos funcionales auxiliares. Proporciona capacitación individualizada y específica del protocolo basada en la experiência del investigador y del personal del sitio, antes de la activación del sitio.
- Revisa las actividades y la calidad del sitio a través de visitas al sitio y fuera del sitio. Realiza actividades de monitoreo y garantiza la seguridad y protección de los sujetos del estudio de acuerdo con el plan de monitoreo, los PBPD de BMS y las mejores prácticas, el protocolo, las Directrices ICH / GCP y otras regulaciones locales según corresponda.
- Realice actividades de Monitoreo de sitio no cegado para proteger a los ciegos del estudio actuando como una fuente de monitoreo secundaria separada del monitor ciego. Incluye actividades de monitoreo del sitio para farmacia, revisión de aleatorización, responsabilidad de medicamentos y conciliación de los productos de investigación cegados. Trabajar con el personal del estudio no ciego, incluidos farmacéuticos o preparadores de medicamentos no ciegos, y comunicarse solo con el personal interno del estudio BMS no ciego durante la realización del estudio.
- Si bien el monitoreo demuestra la capacidad de usar datos para evaluar riesgos, identificar problemas y tomar decisiones apropiadas. Identifica los factores clave y la importancia relativa de un problema. Analice la causa raíz y el sesgo potencial. Busca información adecuada y crea un plan de acción correctivo o preventivo y comunica el proceso de manera lógica y oportuna.
- Realiza actividades de cierre del sitio cuando se completan todas las visitas de protocolo requeridas y el seguimiento.
- Administra múltiples protocolos, en múltiples áreas terapéuticas, que pueden requerir viajes, según la ubicación del sitio asignado y / o el territorio geográfico.
- Asegura la calidad de l

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