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Local Study Manager

hace 7 meses

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El Local Study Manager será responsable de liderar la ejecución en el país de los estudios clínicos globales y dirigir los equipos de estudio locales (LST) para entregar componentes comprometidos de acuerdo con los recursos acordados, el presupuesto y los plazos que cumplan con los documentos de procedimiento de AZ, las pautas internacionales como ICH-GCP, así como las regulaciones locales relevantes.
Además puede realizar el monitoreo del sitio según sea necesario para respaldar el modelo de capacidad flexible y garantizar que los sitios sean identificados, que se realicen las calificaciones correspondientes, que se configuren, se inicien, se monitoreen, se cierren y que se archive la documentación.

**Principales Tareas**:

- Tiene la responsabilidad general de los compromisos de los estudios clínicos a su cargo dentro del país.
- Lidera los equipos locales ( CRA (s) y CSA (s)), para el estudio / estudios asignados
- Coordina el proceso de selección del sitio mediante la identificación de sitios / investigadores potenciales, la realización de la evaluación inicial y la calificación de los sitios potenciales.
- Gestiona o prepara la documentación de los paquetes para presentación ética y regulatoria. Asegura la presentación oportuna de la solicitud / documentos a Comites de ética y autoridad regulatoria.
- Asegura la preparación del presupuesto de estudio clínico para el país y de los contratos con los investigadores.
- Asegura la recolección de los documentos esenciales del estudio clínico, la importación de la droga y materiales del estudio clínico y seteo de las cuentas de los diferentes proveedores de los estudios clínicos.
- Seteo y mantenimiento del CTMS a nível país, coordinación de las actividades de monitoreo y revisión de los reportes de monitoreo
- Puede realizar visitas de comonitoreo o de acompañamiento/ entrenamiento del CRA
- Garantiza que se mantenga completo y actualizado el eTMF.
- Proporciona información periódica a los directores de línea a nível de país sobre los estudios, los hitos y la performance de los miembros del equipo.

**Requisitos**:

- 5 de años de experiência en investigación clínica, gestión de proyectos de estudio locales.
- Experiência en liderazgo o supervisión de equipos y delivery de ensayos clínicos.
- Estudios universitarios finalizados en Biología, Bioquímica, Farmacia, Nutrición, Biotecnología u otras carreras vinculadas a la salud.
- Inglés avanzado (Excluyente)