Ernest Arguelles
Austin,TX
Summary
Experienced with managing clinical trial data, ensuring accuracy and compliance with regulatory standards. Utilizes advanced data management techniques to support clinical research. Track record of leveraging strong analytical skills and software proficiency to improve data processes.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Data Manager Manager
Lantern Pharma Inc.
10.2024 - Current
- Sole Clinical Data Manager responsible for establishing and managing all data management operations for a growing biotech company.
- Developed and implemented comprehensive Data Management Standard Operating Procedures (SOPs) to ensure data integrity and regulatory compliance across all clinical trials.
- Designed, built, and validated Electronic Data Capture (EDC) systems in Medidata Rave, Viedoc, and Zelta, adapting to diverse study requirements.
- Managed all Clinical Data Management (CDM) activities, including eCRF design, data cleaning, query management, and database lock procedures, ensuring timely and accurate data delivery.
- Provided study oversight, monitoring data quality, and proactively addressing data-related challenges to maintain study timelines and objectives.
Clinical Data Manager II
Invicro, LLC
10.2023 - 10.2024
- Developed and implemented comprehensive Data Management Plans (DMPs), Database Lock (DBL) procedures, and Statistical Analysis Plans (SAPs) for Phase I-III clinical trials, ensuring data integrity and regulatory compliance.
- Generated and analyzed tracking and edit check reports, proactively identifying data discrepancies and facilitating timely resolution to maintain data quality.
- Managed study launch and ongoing project activities, optimizing workflows and ensuring adherence to timelines and budget.
- Served as a primary point of contact for sponsors, leading meetings, presenting data updates, and documenting key decisions through detailed meeting minutes.
- Designed and programmed electronic Case Report Forms (eCRFs) for both blinded and open-label trials, contributing to efficient data capture and streamlined data management processes.
- Conducted advanced Excel training sessions, empowering team members with proficiency in XLOOKUP, VLOOKUP, and Pivot Tables, enhancing data analysis and reporting capabilities.
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
Lead Clinical Data Manager
XBiotech Inc.
06.2021 - 10.2023
- Directed Clinical Data Management operations for Early Phase Development, providing strategic leadership and ensuring efficient data management processes across multiple clinical trials.
- Designed and implemented electronic Case Report Forms (eCRFs) for Phase I-III clinical trials (blinded and open-label), optimizing data capture and contributing to study success.
- Collaborated on protocol development, contributing expertise in statistical analysis and randomization procedures to ensure robust study designs.
- Developed and maintained comprehensive Data Management Plans (DMPs), Database Lock (DBL) specifications, and Statistical Analysis Plans (SAPs), ensuring adherence to GCP and regulatory guidelines.
- Contributed to the development of Development Safety Update Reports (DSURs) and Clinical Study Reports (CSRs), supporting accurate and timely reporting of clinical trial data.
- Built and configured Electronic Data Capture (EDC) systems (Zelta/Merative/IBM) for multiple clinical trials, streamlining data collection and management workflows.
- Recruited, trained, and managed a high-performing Clinical Data Management team, fostering a collaborative and efficient work environment.
- Automated weekly study report generation using Python and SAS, providing timely data insights for Medical Review and enhancing data-driven decision-making.
- Managed query generation and data cleaning activities, ensuring data integrity and accuracy throughout the study lifecycle.
- Performed ad hoc data analysis to support study objectives and address data-related inquiries.
- Delivered comprehensive EDC system training to Study Coordinators and Principal Investigators (PIs), ensuring effective utilization of data management tools.
- Oversaw vendor management and drug inventory, optimizing resource allocation and ensuring study supply chain efficiency.
Quality Control Specialist
Advarra
01.2020 - 07.2021
- Performed daily compliance review for hundreds of protocols and ICFs
- Reviewed and approved all subject facing study documentation to ensure FDA compliance
- Performed quality and consistency checks on hundreds of clinical trials
Senior Research Associate
MediaScience
10.2018 - 01.2020
- Instructed subjects on protocol procedures and ICF process
- Performed data collection through the use of biometric equipment in compliance with protocol
- Hired and trained Research Associates
Research Scientist
RTLGenomics
10.2016 - 12.2017
- Performed DNA and RNA extractions to assist with bioinformatics research
Education
80 Credit Hours - Microbiology
Texas Tech University
Lubbock TX80 Credit Hours - Data Management And Analytics
Wester Governors University
Austin TXSkills
- EDC Building: Medidata RAVE, Viedoc, Zelta
- Electronic data capture
- Data cleaning
- Edit Check programming
- Data reporting
- Database design
- Clinical research
- Data validation techniques
- Python
- Excel
Certification
- CompTIA A+ IT Certification
- Certified Zelta Study Designer
- GCP
Timeline
Clinical Data Manager Manager
Lantern Pharma Inc.
10.2024 - Current
Clinical Data Manager II
Invicro, LLC
10.2023 - 10.2024
Lead Clinical Data Manager
XBiotech Inc.
06.2021 - 10.2023
Quality Control Specialist
Advarra
01.2020 - 07.2021
Senior Research Associate
MediaScience
10.2018 - 01.2020
Research Scientist
RTLGenomics
10.2016 - 12.2017
80 Credit Hours - Microbiology
Texas Tech University
80 Credit Hours - Data Management And Analytics
Wester Governors University
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