Javier Dufrechou

Experience

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  GlaxoSmithKline

  Feb 2007 - Oct 2012

  • Liberación de lotes de productos importados y productos de fabricación nacional al mercado: productos de consumo, farma y vacunas. • Manejo de reclamos de clientes de productos locales e importados, derivación y seguimiento de las investigaciones a las diferentes áreas afectadas (localmente o en el exterior).• Control y aprobación de los registros de temperatura durante el transporte de productos que requieren cadena de frío. • Almacenamiento y manejo de la documentación relacionada a los lotes de poductos .• Manejo de desvíos y planes de acción (CAPA´s) asociados. • Manejo de los sistemas informáticos SAP, BPCS y JDE. Show less

  • Analista de Garantía de Calidad

    Oct 2011 - Oct 2012

  • Analista Sr de Control de Calidad

    Feb 2007 - Oct 2011
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  Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

  Nov 2012 - Feb 2013

  Bioquímico

  Rotación por las áreas de Hematología, Bacteriología y Química clínica.Manejo de contadores hematológicos Cell-Dyn 3700 y Cell-Dyn Ruby, elemento analítico modular COBAS 6000, VIDAS y sistema informático OMEGA 3000.Realización de frotis y formula leucocitaria.Análisis de sedimento urinario. Manipulación de muestras biológicas (Esputo, Aspirado traqueal, líquido bronco alveolar, hisopado de fauces, hisopado anal, hisopado vaginal, líquido cefalorraquídeo, líquido pleural, líquido abdominal, líquido sinovial, material quirúrgico y material óseo) Show less

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  Fisher Clinical Services

  Sept 2013 - Sept 2016

  Logistic Project Coordinator

  • Coordinar las recepciones y envíos de medicamentos/materiales a fin de tener un control adecuado del material que ingresa al depósito, verificar su documentación y confirmar al cliente su arribo.• Procesar las órdenes de medicamentos/suministros a los centros de investigación y solicitar los acuses de recibo a fin de cumplir con los requisitos establecidos.• Colaborar y brindar asesoramiento en el proceso de start up de nuevos proyectos,Llevar a cabo el control de inventario para controlar la entrada y salida de insumos y tener registro en toda la cadena de suministro.• Realizar los procesos de retorno, coordinando con los centros el envío de medicamentos/suministros y la verificación de la documentación correspondiente.• Generar el set-up administrativo de los proyectos: crear carpetas, formularios y planillas necesarias para el registro y documentación de la información de cada estudio.• Elaborar los reportes para los clientes informando el status de cada proyecto.• Brindar asesoramiento a los centros médicos sobre los envíos de medicación/suministros, ya sea en las condiciones de almacenamiento, manejo de sensores de temperatura, procedimientos de acuse de recibo y documentación del proyecto.• Detectar y reportar desvíos y no conformidades en la coordinación de los proyectos.• Desarrollar otras tareas que puedan ser requeridas a fin de cumplir con los requerimientos del negocio. Show less

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  DOCS

  Sept 2016 - Sept 2017

  Clinical Research Associate
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  Novo Nordisk

  Sept 2017 - Apr 2020

  Clinical Research Associate
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  IQVIA

  Apr 2020 - Sept 2022

  Centralized Monitoring Lead (CML) partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Centralized Monitor (CM) and Centralized Monitoring Assistant (CMA). Show less Centralized Monitoring Lead (CML) partners with the Clinical Lead and local country Site Monitors in project execution. Provides centralized support to monitoring visits and site management for a variety of protocols, sites and therapeutic areas. Monitors study start-up, manages resources, performs ongoing risk assessment through data trending and analytics and proposes potential mitigating actions in a timely fashion. Leads team of Centralized Monitor (CM) and Centralized Monitoring Assistant (CMA). Show less

  • Senior Centralized Monitoring Lead

    Dec 2021 - Sept 2022

  • Unblinded Clinical Lead

    May 2021 - Sept 2022

  • Centralized Monitoring Lead

    Apr 2020 - Dec 2021
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  GSK

  Sept 2022 - now

  Local Delivery Lead

  • Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project management of study activities within the countries.• Serves as the operational point-of-contact between the central GSK study team and within-country study team. The LDL collaborates closely with local medical and regulatory affairs staff to align on local medical and scientific requirements. Collaborates with the local and above-country teams for conducting study feasibility and site selection within countries.• Accountable for within-country delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations.• Ensures that critical study timelines related to study activities within-countries are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery. • Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.• Identifies and resolves or escalate risks and issues that may impact study delivery.• Provides feedback on performance, capabilities and competencies of study members to line management. Review and approve monitoring visit reports.• Advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites.• Assists with audits/inspections of local clinical operations department & study / sites in the country. Show less