Pre-clinical Project Manager

hace 3 semanas


Madrid, España Morgan Philips Executive Search A tiempo completo

**Misión del puesto**:
Garantizar una adecuada ejecución y seguimiento de los ensayos pre-clínicos delegados a CROs y/o partners en los tiempos y calidad establecidos.

**Funciones específicas**:
Gestionar el plan del ensayo pre-clínico bajo su responsabilidad, comunicando cualquier desviación en los tiempos al jefe de ensayos clínicos y garantizando la implementación de medidas correctoras para su ajuste.

Participar en la selección de CRO y vendors externos requeridos en el Ensayo pre-clinico así como controlar la ejecución de todas sus actividades contratadas asegurando que las diferentes actividades se realicen conforme a los planes previstos (coste-calidad-tiempo).

Participar junto con los posibles partners del estudio y el Jefe de ensayos pre-clínicos en la identificación de los centros e investigadores participantes en el estudio, e identificar los criterios oportunos para garantizar la realización del ensayo en cada centro.

Revisar toda la documentación necesaria de los centros participantes para la obtención de las aprobaciones de CEICs y Autoridades Sanitarias donde se realizará el estudio.

Crear el plan de monitorización del estudio y mantenerlo actualizado a lo largo del mismo.

Revisar y aprobar todos los materiales y guías requeridas por el ensayo pre-clínico.

Supervisar el control de IMPs, su distribución a los centros, manejo, stock en los centros y destrucción garantizando la correcta dispensación y su contabilidad.

Informar a los investigadores sobre todos los aspectos relevantes del ensayo pre-clínico y asegurar su permanente actualización.

Supervisar la calidad de los centros participantes en los estudios monitorizados aplicables a su ensayo pre-clínico.

Participar en la constitución de los posibles Comités Independientes (IDMC, IRC etc) implicados en el ensayo pre-clínico, coordinar sus actividades y mantener el archivo y la trazabilidad de toda la documentación generada necesaria para propósitos de dosier.

Elaborar los documentos de enmienda a los protocolos del ensayo pre-clínico bajo su responsabilidad así como coordinar la aprobación de dichas enmiendas y garantizar que se editan las nuevas versiones de los protocolos si aplicable.

Revisar la documentación relacionada con el desarrollo y seguimiento del ensayo bajo su responsabilidad para garantizar su ejecución frente a los planes establecidos.

Mantener la comunicación en materia del ensayo pre-clínico con los posibles partners participantes en el codesarrollo del estudio. Realizar actualizaciones al menos mensualmente mediante newsletters, organizar las reuniones de Kick off y seguimiento de estudio con todos los agentes implicados en el ensayo pre-clínico.

Creación y mantenimiento del archivo de CROs y de centros. Organizar la transferencia del archivo de estudio delegado a la CRO al finalizar el estudio y realizar el Control de Calidad final del mismo.

Realización de co-visitas de selección, monitorización y/o cierre según se requiera para la correcta ejecución del ensayo pre-clínico. En casos excepcionales también podrá tener centros asignados para monitorización en cuyo caso será realizará tareas de monitor en ese centro.

Organizar y participar en las reuniones de investigadores del ensayo pre-clínico bajo su responsabilidad.

Crear y mantener un sistema de tracking en materia de planificación de tiempos y control de actividades delegadas a CROs (visitas, documentación de ensayo, información de pacientes etc), actividades por países, reclutamientos y gestión de vendors.

Garantizar el cumplimiento de los procedimientos de la Compañía, de las Buenas Prácticas Clínicas y de la Legislación aplicable en todos los ensayos pre-clinicos bajo su responsabilidad.

**Requerimientos del puesto**:
Licenciado en Ciencias de la Salud.

Nível de inglés muy alto (mínimo C1).

+3 años de experiência en gestión de proyectos en fase pre-clínica en áreas de desarrollo clínico y en otras actividades relacionadas con el desarrollo de ensayos pre-clínicos.

Experiência valida como monitor de ensayos pre-clínicos o coordinador de estudios internacionales.

Imprescindible conocimientos de la legislación en materia de ensayos clínicos internacionales.



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