Juan Ignacio Terraza Email & Phone Number

Spain

Buenos Aires, Argentina

• Participation in selection of the Risk-Based Monitoring (RBM) system and providing relevant training to the project team and/or Sponsor• Set up and maintenance of RBM systems in collaboration with Central Monitoring Manager• Establishment of data extract, loading and transformation process for a study, management of large complex datasets (including unstructured data) coming from multiple data sources• Mapping, mining and classifying raw data and pulling processed data into PSI data platform• Programing and producing data listings, tables and figures for Clinical Data Reviewers and Central Monitoring Managers• Calculation of Key Risk Indicators and Quality Tolerance Limits, applying advanced analytical technics to identify data trends and patterns for Centralized Monitoring• Collaboration with Central Monitoring Manger and cross-functionally to identify study challenges, development of an action plan and data solutions, providing outputs actionable for project team• Effective communication and explanation of data findings and solutions to cross-functional stakeholders• Participation in development and programming of databases and software products for Centralized Monitoring• Participation in development of processes, Quality System Documents (QSDs) and internal instructions for Centralized Monitoring

Buenos Aires, Argentina

Description:1. Line management of Associates, Process Improvement2. Process Improvement & Business Analytics2.1. Participation in the development of quality systems documents and businessprocess descriptions2.2. Management of assigned process improvement projects2.3. Assistance in the implementation and maintenance of the systems for collection,analysis and reporting/distribution of employee/site/client feedback; best practicesand lessons learned; innovation ideas2.4. Summarizing information on current and future industry trends in support ofproposals to create new, or enhance current products and services2.5. Preparation and conduct of training in process improvement, its methods, tools andtechniquesTasks:- Set-up of RBM analyses (KRI, DQA, QTL) using Excel, SAS code, and/or CluePoints platform.- Analysis of signals detected by DQA and other kinds of assessments, from a medical standpoint.- Creation and maintenance of data converters to calculate regular or one time metrics based on available data sources.- Creation and maintenance of Office add-ins, macro enabled documents, and databases to automatize daily tasks, using VBA, VB.net, javascript, other Visual Studio languages, and SQL or SAS code.

administrative supervision of the department staff; review of scientific literature; preparation of feasibility questionnaires and surveys; participation in scientific conferences, meetings, symposia; development and maintenance of the clinical facilities and equipment database; staff training; review and development of quality systems documents related to Feasibility Department

assessment of patient recruitment strategies; analysis of country/site performance; evaluation of potential sites; participation in scientific conferences, meetings, symposia; review of scientific literature; research on therapeutic indications and study drug information; preparation and review of feasibility questionnaires; preparation and maintenance of investigator tracking logs; training of the Feasibility Research and Patient Recruitment Services staff

review of scientific literature; research on therapeutic indications and study drug information; preparation and Review of feasibility questionnaires; preparation and maintenance of investigator tracking logs; training of the Feasibility Research and Patient Recruitment Services staff

• Visitas de Iniciación y Visitas de Monitoreo, en Buenos Aires y otras localidades.• Traducción de documentos médicos. • Manejo de Documentos regulatorios (Autoridades hospitalarias, Autoridades locales, CIOMS).• Participación de visitas pre-auditoría y de auditoría.• Participación de Meetings y Teleconferencias con representantes de Sponsors internacionales.• Recepción, reporte y seguimiento de Eventos Adversos Serios.

Biología Molecular Para Médicos

Médico