Summary
Overview
Work History
Education
Skills
Contributions and Achievements
Certification
Timeline
Generic

Kobe Dillinger

SCOTTSDALE,AZ

Summary

Highly motivated and detail-oriented Veeva implementation specialist with defined skill as a Clinical Data Management Specialist and extensive experience supporting rare disease clinical trials. Proficient in electronic data capture (EDC) system development and CMTS system deployment, query resolution, document management, and analyzing study protocols to ensure accurate data collection and compliance. Adept at facilitating cross-functional collaboration and maintaining data integrity in complex clinical research environments.

Overview

1
1
year of professional experience
1
1
Certification

Work History

Clinical Trial Assistant (CTA) / Consultant

Applied Therapeutics
05.2024 - Current
  • Prepares study team agendas, responsible for taking meeting minutes and distributes study team agenda(s), meeting minutes and action items
  • Performs detailed eTMF CRO quality check reviews with follow-up for missing documentation under the supervision of the TMF Leader
  • Assists with filing and archiving project documentation in the eTMF within the defined timelines
  • Performs eTMF internal reviews, reconciliation and study file archival
  • Contribute to inspection readiness, including, but not limited to, creating and updating various folders and trackers, study team lists (internal, CRO and vendors), internal study team meetings, country specific documents and all other documents as requested by Clinical Operations
  • Maintains sponsor team member staff assignment list for Veeva systems e.g ETMF, EDC, CTMS, quality review into Veeva compliance docs for training
  • Act as central point of contact for the clinical team for designated projects, communications, and associated documentation

Education

Bachelor of Arts - Applied Business And Technology Solutions

Arizona State University
Tempe, AZ

Skills

  • Electronic data capture
  • Data management
  • Standard operating procedures
  • Clinical data review

Contributions and Achievements

  • Supported data entry for 2 rare disease clinical trials, ensuring accuracy and compliance with protocol and regulatory requirements.
  • Organized and standardized electronic storage of source documents, including developing and implementing naming conventions for streamlined access and retrieval.
  • Analyzed study protocols to guide design and development of CRFs, edit checks, and CRF completion guidelines (CCGs) in collaboration with the Lead Data Manager.
  • Assisted in User Acceptance Testing (UAT) and CRF design for 3 EDC system go-lives, ensuring functionality aligned with study needs.
  • Lead User Acceptance Testing (UAT) for CTMS design.
  • Drafted and revised key clinical documentation, including CRF Completion Guidelines (CCGs) and the Data Management Plan (DMP), to support trial objectives.
  • Acted as a point of contact for query resolution, successfully managing and closing out outstanding data queries within established timelines.
  • Coordinated and scheduled meetings with EDC vendors, effectively managing team schedules and fostering communication during the EDC build phase.
  • Contributed to the design and implementation of efficient workflows to support rare disease clinical trials from start-up to close-out.

Certification

ICH Good Clinical Practice (GCP) Training


Timeline

Clinical Trial Assistant (CTA) / Consultant

Applied Therapeutics
05.2024 - Current

Bachelor of Arts - Applied Business And Technology Solutions

Arizona State University

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Kobe Dillinger