Clinical Site Data Monitoring (CSDM) Services en DOCS Global

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Clinical Site Data Monitoring (CSDM) Services

Fecha de la oferta: 13 Sep.
Empresa que publica esta oferta: DOCS Global
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DOCS specialises in delivering strategic resourcing solutions to the biopharmaceutical and medical device industries and has been a leader in the field for over seventeen years since its establishment in 1997.

Our Services:
Our full-spectrum resourcing solutions include Functional Service Provision (FSP), Contract Placement, Permanent Placement and Executive Search.

Our Clients:
DOCS’ clients include all of the world’s top 20 pharma companies and a range of mid-sized pharma and biotech organisations.

Our History:
Founded in 1997, DOCS grew to become the premier staffing provider to the clinical development industry. The company was acquired by ICON plc. in 2007 and was merged wi
Número de vacantes: 1
Provincia/s: Madrid

Descripción

Descripción: This is a great job opportunity to be part of an international pharmaceutical company!
You will act as the primary contact for the Investigative Site for all data related questions, issues, support, training and performance tracking and communication: • Responsible for data quality management activities for assigned sites at the country level for specific protocols • Performs the initial and ongoing training to Investigator, including site personnel, and provides trainings on data management related tools and processes, if needed. • Ensures account Activation and Site start up training is performed according to the established timelines. • Monitors and tracks the progress of assigned sites regarding timely data submission/entry, discrepancy resolution, eCRF page approval as well as completeness and accuracy of data based on findings from data review performed by Central Monitor and Clinical Data Reviewer. • Proactively collaborates with other study team members to address issues related to address issues related to data quality at the site level.
Edad máxima para el puesto: 65 años.
Tipo de contrato: Indefinido
Ventajas sociales o económicas: This is a full time, permanent and partially client office based in Spain.

As for DOCS, we are the Functional Resourcing Division (FSP) division of ICON Plc. This means that when you join the DOCS Team you will work exclusively with, and be fully dedicated to one of our many pharmaceutical / medical device partners working on their SOPs, IT Systems, Projects and sometimes in our partner’s offices. We partner with many of the world’s leading pharma companies so in return we are able to offer enviable career and development opportunities for our employees.

Observaciones: Negotation skills
Experience in working with clinical trial sites.
Knowledge in techniques to deliver effective training and communicate on systems or study specific information.
Understanding of customer relationship importance, including proactive and reactive mindset and actions.
Experience in immuno-oncology a clear advantage.

Requisitos

Requisitos: • With a Bachelor degree (or local equivalent) in a health related field and with 2-5 years of clinical or developmental experience and Experience in immuno-oncology is a clear advantage.
• Knowledge of data review process and Database Management Systems including eDC systems. Knowledge of ICH-GCP guidelines and local regulatory regulations.
• Knowledge of general clinical research including investigator site issues, important milestones and strategies to ensure timelines are met.
• Knowledge of techniques used to lead effective meetings and the use of presentations to communicate plans.
Knowledge in techniques to deliver effective training and communicate on systems or study specific information.
Fluent in English
Nivel de estudios mínimo requerido: Licenciado
Idiomas requeridos: Inglés nivel Alto.
Experiencia profesional mínima requerida: 2 años
Disponibilidad para viajar requerida: El 20% del tiempo laboral

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Esta oferta ha recibido 78 inscripciones.