Clinical Lead

hace 2 semanas


Barcelona, España Page Personnel España A tiempo completo

Sus responsabilidades se centrarán en la coordinación y planificación de los ensayos clínicos de los dispositivos de la compañía; en la preparación de documentación clínica siguiendo los requerimientos de la nueva regulación MDR e ISO14155; Interacción y coordinación de reuniones con KOLs, Investigadores y CROs; Revisión literatura científica; Soporte a Dpts. Comercial y Marketing.
- Coordinación, Gestión, Planificación y Monitorización de Investigaciones Clínicas (Estudios Clínicos, Ensayos Clínicos, Clinical Trials) con PS
- Diseño de eCRF ó eCRD _(electronic Case Report From, Cuaderno recogida de datos electrónico)_
- _Monitorización online, telefónica y presencial_
- Coordinación de CROs e Interacción con KOLs, así como liderar las reuniones pertinentes
- Preparación de Planes Evaluación Clínica (CEP) según MDR
- Preparación Informes y Planes de seguimiento clínico poscomercialización (PMCF)
- Preparación informes de seguridad y eficacia clínica (SSCP)
- Prepración de Planes de Seguimiento Poscomercialización y Vigilancia (PMS)
- Preparación Informes Periódicos de Seguridad actualizados (PSURs)
- Revisión literatura científica y manejo gestor bibliográfico
- Soporte Dpt. Comercial y Marketing

Medical devices para Terapias Intervencionistas|Evaluación clínica y seguimiento post-comercialización
- Grado en ciencias de la salud. Valorable PhD
- Indispensable Máster en Monitorización de Ensayos Clínicos o CRA
- Imprescindible experiência mínima de 2 años en Ede PS o fármacos
- Valorable conocimiento y experiência en Nuevo Reglamento (UE) 2017/745 sobre Producto Sanitarios
- Valorable conocimiento y experiência en ISO14155
- Nível alto de inglés (_Advanced, C1_)
- Capacidad analítica
- Persona proactiva y colaborativa
- Eficacia, rigurosidad, dinamismo y organización
- Buena comunicación

Importante compañía que desarrolla y fabrica medical devices para Radiología y Cardiología Intervencionista
- Contrato indefinido
- Oportunidades de carrera y desarrollo profesional.

LI-DNP

Importante compañía que desarrolla y fabrica medical devices para Radiología y Cardiología Intervencionista está en búsqueda de un/a Clinical Lead que tendrá la misión de garantizar la seguridad y la eficacia de los productos, mediante la evaluación clínica y seguimiento post-comercialización.

Clinical Lead


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