Clinical Data Management/Data Coordinator/Operations Support Analyst

J. G. Ortega_Curriculum Vitae Page * of *

Jose G. Ortega

Bonsall, CA 92003 760-***-**** ***********.*@*****.*** www.linkedin.com/in/jose-g-ortega-a0514b278/ DATA MANAGEMENT PROFESSIONAL

Bilingual, results-driven data management professional known for building and maintaining positive, productive relationships. Collaborative and individual contributor with demonstrated successes in partnering with diverse, cross- functional teams, assist with data reports, data extraction, audits, and reconciliation, troubleshoot data sources and databases.

CORE COMPETENCIES

Languages: English - Native Spanish – Fluent Quality Assurance Risk Identification / Mitigation Compliance Best Practices Continuous Process Improvements Reporting Training Research Documentation Audits Vendor Management

TECHNICAL PROFICIENCIES

Clinical Trials Database Open Activities Data Review Data Cleanup Electronic Data Transfer Metrics Case Report Forms (CRFs) Database Closing Activities Medical Coding Analytics Legal / Regulatory Guidelines Requirement Assessments Troubleshooting Microsoft Office – Word, Excel, PowerPoint, Outlook, Access, Teams ADP SharePoint WebEx Zoom Informatica Viewpoint CERTIFICATIONS

Medidata Training via Synteract, Carlsbad CA, 2014: Medidata Rave 360 Reports Rave EDC Essentials for Investigators

Rave EDC Essentials for Clinical Research Associates (CRAs) Rave EDC Essentials for Research Coordinators. CLINICAL TRIAL EXPERIENCE

Phase I – IV

Therapeutic Area Experience: Oncology, Rare Disease, Aesthetics, Dermatology, CNS, Women’s Health, Infectious Disease, Immunology, Healthy Volunteers, Cardiovascular/Metabolic, Ophthalmology, Gastroenterology CLINICAL DATA MANAGEMENT DATABASE EXPERIENCE

Medidata RAVE® Medrio Oracle Inform Veeva DATATRAKTM TrialMaster® SynCaptureTM DataFax® and iDataFax® Informatica Viewpoint

EXPERIENCE

Operations Support Analyst, Abbott Vascular 10/2023 – 12/2023 Completed tasks and processes for assigned product family requests. Generate reports for GTIN (global trade item number)/UDI (unique device identifier) review. E-mail teams at manufacturing sites. Implement site team updates to Informatica. Update product statuses in Quasar Tracker.

Search Informatica & Viewpoint databases for product information.

Generate product reports for GTIN/UDI review.

E-mail manufacturing site team members product reports, request product review and update.

Implement manufacturing site team updates to Informatica.

Update Quasar Implementation Tracker.

Senior Clinical Data Coordinator, Synteract, a Syneos Health Company 07/2014 – 12/2022 Clinical Data Coordinator 07/2011 – 06/2014

Completed tasks and processes for assigned clinical studies. Executed database opening tasks and daily database maintenance. Coordinated data study activities (electronic data transfer, data cleaning, data metrics, and database closing). J. G. Ortega_Curriculum Vitae Page 2 of 2

Developed CRFs for data collection.

Followed project Data Management Plan (DMP), and developed / implemented DMP for new projects.

Coordinated CRF / Data Clarification Form (DCF) tracking, if applicable for the project.

Performed Quality Control (QC) activities related to the database open.

Create subject test data for database validation.

Performed data entry / data verification tasks.

Worked day to day with Data Manager to address data issues.

Reviewed data, wrote data queries, resolved, and modified data discrepancies per resolutions.

Generated, formatted, and sent data discrepancy reports to clinical sites, Sponsor and monitors.

Updated the clinical database following data query resolutions.

Communicated with the Sponsor as needed regarding data / database issues.

Learned / leveraged sufficient SAS programming to produce simple reports, using SAS to review clinical datasets. Clinical Data Management Assistant, Synteract, 01/2008 – 06/2011

Assisted with database opening procedures and helped test the database.

Created and tested edit checks, reviewed / maintained clinical data, client communication.

Clinical site and client training for using EDC database.

Wrote, sent, and resolved data queries, assisted with data audits and database close activities. ADDITIONAL RELEVANT EXPERIENCE

Payment Processing – Order Processing – Policy Management

BodyWise International – DJ Orthopedics – Farmers Insurance

Order department taking and processing orders and payments.

Managing monthly product subscriptions, managing monthly payments.

Receiving, sorting policy payments and processing (batches of thousands).

Monthly payment and data audits, payment reconciliations, reporting discrepancies. Senior Clinical Data Entry Specialist, Favrille Inc.

Tracked all CRFs, DCFs.

Maintained subject CRF filing system.

Trained new data entry personnel.

Assisted with subject clinical data audits.

Clinical Data Entry Specialist, Isis Pharmaceuticals

First-pass, second-pass, and data verification activities as applicable.

Maintained clinical data filing system.

Assisted with department clinical data documentation maintenance. EDUCATION

Associate Degree, General Education

MiraCosta College, Oceanside, California

PROFESSIONAL DEVELOPMENT

Trial Master Overview Training, Synteract, CA, 2015

General ICH-GCP Annually, Synteract, CA 2008-2022 REFERENCES

Available upon request

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