Te ofrecemos formar parte de una compañía en crecimiento a nivel nacional e internacional y trabajar en una de las empresas españolas que ofrece mayor desarrollo y estabilidad profesional.
Buscamos a gente joven, con ganas de evolucionar, innovar y aprender y también profesionales consolidados en el sector farmacéutico nacional e internacional que puedan aportar know how y experiencia a la compañía.
Contamos con un área industrial muy importante en la que continuamente buscamos profesionales para nuestras líneas de producción y laboratorio. Destacamos nuestra estrategia en investigación por lo que los doctores en ciencias de la salud son claves para nosotros. En ventas, tenemos una red
Madrid
17 Mar.
Buscamos a gente joven, con ganas de evolucionar, innovar y aprender y también profesionales consolidados en el sector farmacéutico nacional e internacional que puedan aportar know how y experiencia a la compañía.
Contamos con un área industrial muy importante en la que continuamente buscamos profesionales para nuestras líneas de producción y laboratorio. Destacamos nuestra estrategia en investigación por lo que los doctores en ciencias de la salud son claves para nosotros. En ventas, tenemos una red
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Descripción • Assistance to the Clinical Project Manager in the preparation, execution and closure of clinical trials.
• Assistance to the members of the project team in administrative, logistical and practical tasks, including follow-up, collection, distribution and presentation of the study documentation.
• Ensure adequate tracking and monitoring of all activities, documents and reports with the required format for delivery within the agreed deadlines.
• Request and review regulatory documents as required.
• Participate in the development of the study and the implementation of the process, including drafting and revision of study documents; clinical trial planning, ICFs, eCRF, organization and presentation at investigators meetings, and/or development of specific CRA project trainings.
• Support in the preparation of shipment of supplies related to the clinical trial.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Conduct oversight visits for monitoring if required.
• Follow up and supervise the data collection of the ongoing study.
• Contribute to ensure effective project plans are in place for the study.
• Contribution to Monitoring and resolution of audit findings.
• Review financial issues and bill payments as defined in the study contracts.
• Scalate important topics or any potential quality issues to Clinical Project Manager and Clinical Operations Manager.
Descripción • Assistance to the Clinical Project Manager in the preparation, execution and closure of clinical trials.
• Assistance to the members of the project team in administrative, logistical and practical tasks, including follow-up, collection, distribution and presentation of the study documentation.
• Ensure adequate tracking and monitoring of all activities, documents and reports with the required format for delivery within the agreed deadlines.
• Request and review regulatory documents as required.
• Participate in the development of the study and the implementation of the process, including drafting and revision of study documents; clinical trial planning, ICFs, eCRF, organization and presentation at investigators meetings, and/or development of specific CRA project trainings.
• Support in the preparation of shipment of supplies related to the clinical trial.
• Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures
• Conduct oversight visits for monitoring if required.
• Follow up and supervise the data collection of the ongoing study.
• Contribute to ensure effective project plans are in place for the study.
• Contribution to Monitoring and resolution of audit findings.
• Review financial issues and bill payments as defined in the study contracts.
• Scalate important topics or any potential quality issues to Clinical Project Manager and Clinical Operations Manager.
Número de vacantes:
1
Modalidad de trabajo:
Presencial
Tipo de contrato:
Indefinido
Requisitos
• Higher degree in Health Sciences
• Minimum two years of clinical research experience at a Sponsor or CRO. Must have knowledge of clinical research concepts, practices, guidelines and regulations covering clinical trials.
• Experience in observational studies will be very valuable
• Read, write and speak fluent English
• Travel availablity: 30%
• Minimum two years of clinical research experience at a Sponsor or CRO. Must have knowledge of clinical research concepts, practices, guidelines and regulations covering clinical trials.
• Experience in observational studies will be very valuable
• Read, write and speak fluent English
• Travel availablity: 30%
Estudios mínimos
Licenciado
Idiomas
Inglés nivel Perfecto.
Experiencia mínima
2 años
Disponibilidad para viajar
El 40% del tiempo laboral