Clinical Trial Lead
hace 5 meses
El/la Clinical Trial Leader es responsable de la gestión operativa de los ensayos clínicos a nível internacional (nível trial) desde la fase de preparación e inicios hasta el cierre de la base de datos y elaboración del informe final. Se encarga de asegurar la viabilidad del estudio, así como los plazos, presupuesto y calidad de los datos, alineando para ello al trial team y a los diferentes países participantes del estudio.
También es garante de que el ensayo se desarrolle observando estrictamente los principios GCP y la legislación y regulaciones internas así como las de aplicación en cada país según corresponda, debe evaluar proactivamente los riesgos del ensayo y diseña e implementa acciones y planes destinados a mitigarlos.
***Funciones & Responsabilidades**:
- Desarrollar y ejecutar exitosamente la gestión de los ensayos clínicos bajo su responsabilidad.
- Desarrollar y dirigir la implementación de los planes de risk management and mitigation.
- Coordinar las diferentes funciones que conforman el trial team a nível internacional.
- Coordinar los CTMs y supervisar la actividad de los diferentes países que participan en el estudio
- Trabajar con todas las funciones y vendors para asegurar que todos los procesos y materiales necesarios para los estudios están listos antes del inicio del estudio y asegurar su correcto funcionamiento a lo largo del mismo.
- Proveer las herramientas necesarias para facilitar la submission y dar apoyo durante el proceso de evaluación y aprobación de los estudios en todos los países participantes.
- Planificar y controlar el stock de medicación necesario para el estudio en colaboración con CTSU.
- Elaboración del protocolo en colaboración con otras funciones como TMM, CTPh, TSTAT...
- Elaboración del informe final y posibles informes interinos del estudio en estrecha colaboración con el MW (si aplica).
- Responsable del archivo del ensayo (TMF) a nível internacional.
- Colaborar con las diferentes publicaciones del ensayo en revistas científicas, congresos, y otros eventos de carácter científico.
- Participación activa en distintos foros funcionales (MST, CTL fórum )
**Perfil & Requisitos**:
- Licenciatura en ciencias de la salud (farmacia, biología, medicina, etc.)
- Experiência previa mínima de 5 años en la industria farmacéutica gestionando ensayos clínicos.
- Nível alto de inglés.
- Conocimiento de regulación de ensayos clínicos y Buena Práctica Clínica (GCP)
- Excelentes habilidades de gestión de proyectos y de organización
- Habilidades de comunicación verbal y escrita, especialmente en inglés.
- Alta capacidad de trabajo en equipos multiculturales.
- Capacidad de liderazgo e influencia. Persona con foco en el paciente y en el investigador y en el entendimiento de sus necesidades
IamBoehringerIngelheim porque
Estamos continuamente trabajando porque queremos diseñar para ti la mejor experiência. Estos son algunos ejemplos de cómo te cuidaremos:
- Horario flexible
- Seguro de vida y accidente
- Seguro médico a un precio competitivo
- Inversión en formación y desarrollo
- Cuidado de la salud
- Portal de ofertas para colaboradores
- Smartworking
Si has leído hasta aquí, ¿qué esperas para aplicar? Queremos saber más de ti
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