Clinical Trial Leader

hace 2 semanas


Barcelona, España Boehringer Ingelheim A tiempo completo

**Clinical Trial Leader**
**-**
**233808**
- En Boehringer Ingelheim desarrollamos terapias innovadoras para mejorar la salud de las personas y los animales. Como empresa familiar fundada en 1885, Boehringer Ingelheim tiene una perspectiva a largo plazo._
- Hoy somos 52.000 personas trabajando en todo el mundo, fomentando una cultura diversa, colaborativa e inclusiva. Creemos que, si tenemos personas talentosas y ambiciosas apasionadas por la innovación, no hay límite para lo que podemos lograr._

**Clinical Trial Leader (CTL)**
- 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.- El/la Clinical Trial Leader 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 _
- Con nosotros, puedes crecer, colaborar, innovar y mejorar vidas. Te ofrecemos desafíos en un ambiente laboral global, respetuoso y familiar, donde las ideas impulsan nuestra mentalidad innovadora. Además, el aprendizaje flexible y el desarrollo continuo de nuestro equipo es clave, porque tu crecimiento es nuestro crecimiento._
- 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_
- Si has leído hasta aquí, ¿qué esperas para aplicar? Queremos saber más de ti_

**Puesto**
- Operaciones clínicas

**Ubicación principal**
- Europe-ES-Cataluña-Sant Cugat del Vallès

**Organización**
- ES-Boehringer Ingelheim España, S.A.

**Horario**
- Tiempo completo



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