Hi! My name is Nelson Rueda Argumedo, I’m a current student in the Master of Public Health and Health Care Management at NYU. I have 3 years of experience working in the clinical data management area and 5 years as a pre-clinical and clinical researcher in the Diabetes field. Currently, I’m looking for a 2024 internship within the pharmaceutical and healthcare industry. Looking forward to sharing all my knowledge with you!

Double Degree in Biology and Microbiology
Concentration in biomedical sciences

Universidad de los Andes

Universidad de Buenos Aires

• Maintains awareness of the pertinent elements of the contract and scope of work for assigned project(s) and communicates status updates to the Project Manager as necessary.
• Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s).
• Creates and enters test data for User Acceptance Testing (UAT). Performs User Acceptance Testing (UAT) for data entry screens, edits and data review listings, all different roles used in the study, and Targeted Source Data Verification (SDV) configuration and matrices.
• Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Resolves answered queries and re-queries where appropriate.
• Performs DM quality review and/or other internal QC checks as required per applicable electronic data capture (EDC) systems. Creates electronic storage media per SOPs for EDC studies.
• Participates in internal meetings and internal/external audits as required.
• Coordinates the work of CDAs assigned to the project and provides training on data management activities and systems. Provides project-specific training to other Clinical Data Associates (CDAs).
• Completes tasks within the timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Proactively communicates accurate estimates on time to the project team and management to complete tasks.
•  Performs Serious Adverse Event (SAE) reconciliations.
• Performs post-migration testing on screens, edit checks, matrices, and role changes as required.
• Participates in customer and third-party meetings distributing relevant information to the internal team.
• Reviews database design specifications (including configuration, data structures, and annotated CRFs).
• Updates the Data Management Plan under the guidance of the PDM.
• Creates and updates the CRF/eCRF Completion Guidelines

Lead Clinical Data Associate III

• Identifies, resolves, and updates data discrepancies. Makes changes to the data management database as required. 
• Generates, tracks and resolves data clarifications and queries. May implement CRF design in identified graphic design package. 
• Reviews data listings for accuracy and consistency of data. Analyzes and resolves data validation and other data management reports. 
• Produces project-specific status reports for CDM management and for clients on a regular basis. 
• Performs data management activities such as Serious Adverse Event and Third-Party Vendor reconciliations as well as Data Listing reviews.

Clinical Data Associate II

• Receives the study related paper documents from sites or other functional areas, and transfers to data entered for processing. 
• Performs Sponsor Data Entry as applicable per data management plans following entry guidelines.
• Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities
• Execute data validation activities in accordance with relevant Standard Operating Procedures.
• Raises questions to investigational site staff and internal and external vendors, reviews responses and corresponding data corrections to confirm identified issue resolution.
• Responsible for the execution of user acceptance testing of data management tools under the guidance of the Senior Clinical Data Manager/Lead Clinical Data Manager. Escalates overdue items, including but not limited to outstanding questions and missing visits.
• Assists the Senior/Lead Clinical Data Manager with data management activities to resolve all identified data issues prior to study database lock.
• Complete trial level archiving activities under the direction of the Senior Clinical Data Manager/Lead Clinical Data Manager including, but not limited to, filing of essential documentation.
• Performed Manager escalations

Clinical Data Manager

\- Generar Células  pancreáticas por reprogramación directa para futuras bases en terapias celulares de diabetes.
\- Descubrir y caracterizar pequeñas moléculas que juegan un rol importante en el proceso de transdiferenciación de fibroblastos hacía células beta pancreáticas con el fin de entender fenómenos de plasticidad celular y reprogramación de células somáticas linaje-específico. Adicionalmente, generar una plataforma más efectiva para el modelamiento de dicha enfermedad humana.
\- Desarrollar diseños experimentales para ensayos in vivo e in vitro relacionados con reprogramación celular a partir de células somáticas, madre y pluripotentes inducidas (iPS)
\- Liderar un grupo de biotecnólogos, técnicos en bioterio, cirujanos, bioquímicos y biólogos para testear seguridad clínica en modelos preclínicos. Procedimientos in vivo: trasplante de islotes, ensayos de teratomas, cuidado animal, desafíos de glucosa, detección de insulina y péptido C (ELISA e IMMULITE).
\- Desarrollar buenas prácticas de fabricación (GMP) para los ensayos in vitro e in vivo/pre-clínico.
\- Dirigir y realizar técnicas moleculares (e.g Extracción de RNA/DNA/Proteína, RT-PCR, qPCR, microarrays), técnicas inmunologicas (e.g. ELISA, citometría de flujo, inmunohistoquímica, inmunocitoquímica, western blot, dot blot, northern blot), técnicas epigenéticas (e.g. Conversión de bisulfito y ChIP), técnicas involucradas en células madres (e.g. Ensayos de teratomas, mantenimiento de cultivo celular, pasaje, criopreservación, feeder layers), genética molecular (e.g. RNAi, electroporación), procedimientos In Vivo en ratones (e.g. trasplante de islotes en páncreas y riñón, inducción de diabetes por STZ), manipulación de animales (Cepas de ratón BalbC/C57/Nude/SCID) y tecnologías de imagines y microscopía (e.g. confocal, marcación celular con rastreadores celulares).
\- Colaborador en proyectos de silenciamiento y activación génica con el sistema CRISPR/CAS9 en líneas celulares 293K y fibroblastos.

Nelson Rueda Argumedo

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