CTA, Medical Affairs (6 meses) en Linical - Pharma Resourcing Solutions (PRS)

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CTA, Medical Affairs (6 meses)
Linical - Pharma Resourcing Solutions (PRS)
Linical- Global CRO cuenta con 24 años en España y alrededor de 800 empleados, siendo España el segundo país en cuanto a volumen de profesionales especializados. Servicios de Investigación Clínica son: Puesta en marcha y Monitorización de EECC, Gestión de Datos, Estadística, Redacción Científica, FV, Auditoría y Diseño de e-CRDs en proyectos de investigación clínica Fases I -IV y en Estudios de Post Comercialización con y sin fármaco -Observacionales, Epidemiología y Farmacoeconomía. Asimismo, la división de Pharma Resourcing Solutions (Linical-PRS) está especializada en selección y contratación de perfiles para la Industria Farmacéutica en los Departamentos Médicos y de Operaciones Clínicas
Madrid, 5 May.
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Descripción
Description of the tasks / routine work:
1. General services.
- Agenda, preparation and detailed minutes of the Local Project Meeting, or other local meetings if applicable.
- Generate Confidentiality Agreements.
- Support in the development procedures as required. Audit support.
- Provide support in the preparation of materials for presentations or meetings
- Corporate support (report preparation: Profarma, INE, Pharmaindustry)
- Specialist Back Up

2. Technical Support for Data Generation:
2.1. Academic research:
- Assistance to review committee: Upload proposal to database for evaluation if applicable, produce approval letter, signature support, shipping to promoter
- Support in the Fair Market Value determination of proposals
- Contract Preparation Support: prepare and launch contract request, signature management, distribution, monitoring.
- Coordination of the internal review of protocols and amendments
- Request, distribution and control of Investigator Manuals to sponsors.
- Support for the request, distribution of documentation to sponsor (eg annual reports of security, security language updates)
- Support / assistance to drug management: request for forecasts to promoters, assistance in the label management, final accounting, destruction, processing of drug orders and associated administrative work, including temperature deviations, metrics, alerts for Expiry dates.
- Maintenance of drug management database: account management, updating and quality control.
- Support to the management of invoices: application against milestone, tracking and archiving
- Assistance in the maintenance of electronic repositories of all essential documents (prepare and archive electronic documents)
2.2 Research promoted by the sponsor:
- Maintenance, update and quality control of internal databases
- Support for the registration and maintenance of public records when applicable (ClinTrials, AEMPS)
- Support in preparing reports on the status of studies and distribution as required.
- Support in monitoring regulatory approvals when applicable.
- Support and organization of Researchers meetings, including agendas and preparation and distribution of minutes.
- Continued support for archiving and participation in the reconciliation of TMF, at the request of the Specialist.
- Follow up of researchers payments when made from the sponsor.
- Assistance in the preparation of contracts with the sites: signature management, distribution, tracking. When required, assistance in adapting contracts to the local requirements and sponsor standards.

3. Data Dissemination Technical Support:
- Support in the maintenance of publications plan
- Management of the publication in the Global Publications System: register, send and monitor
- Author Agreement Letters, upload documents to the system, process planning, monitoring of approvals, obtaining disclosures ...
- Support to the Management of encores (follow-up national / international authors; management of translation and validation with the RML) and posters, abstracts and / or oral communications.
- Carry out submissions to national congresses; acceptance / rejection of the publication.
- Assistance in contacts with Medical Writer (compendiums), billing and archiving.
- Reconciliation of bases of Medical Information.

Personal skills:
- Ability to work in a team and independently
- Effective time management and organizational skills
- Communication skills
- Sense of responsibility

Numero de vacantes: 1
Tipo de contrato: Temporal

Ventajas sociales o económicas
Social benefits Package
"
Requisitos
Personal skills:
- Ability to work in a team and independently
- Effective time management and organizational skills
- Communication skills
- Sense of responsibility

Estudios mínimos
Diplomado
Idiomas
Inglés nivel Alto.
Experiencia mínima
1 año
Disponibilidad para viajar
Ninguna



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