Summary
Overview
Work History
Education
Skills
Timeline
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Courtney Craven

Kenmore,WA

Summary

Detail-oriented Study Data Specialist with several years of experience managing clinical trial data, ensuring data accuracy, integrity, and compliance with regulatory standards (FDA, ICH-GCP, CDISC). Experienced in data mapping and complex problem-solving, I have successfully managed deliverables for approximately 25 clinical trials simultaneously. Recognized for my ability to operate quickly and effectively under pressure, while maintaining the quality of the product.

Overview

6
6
years of professional experience

Work History

Study Data Specialist

Clinical Ink
Winston Salem, North Carolina
06.2023 - Current
  • Create and review data export mapping specifications based on customer analysis and needs.
  • Work with the sponsor and CRO to determine all data services deliverables.
  • Ensure associated deliverables meet the expectations of ICH GCPs, data standards, and internal procedures.
  • Triage, research, and provide solutions for identified data issues.
  • Participate in departmental discussions regarding technical, functional, and process improvements.
  • Manage study deliverables for approximately 25 clinical trials simultaneously.0

Validation Analyst

Clinical Ink
Winston Salem, North Carolina
05.2021 - 06.2023
  • Wrote and executed clinical trial form test cases using QTest and Jira
  • Conveyed errors found during testing to other teams in a clear and concise manner
  • Developed a standardized method for determining number of cases to test
  • Participated in efforts to streamline testing process

Office Assistant

Wake Forest University Department of Music
08.2019 - 05.2021
  • Completed basic administrative duties
  • Acted as a representative of the department at concerts and lectures
  • Coordinated marketing campaigns for department events
  • Proofed concert programs prior to printing
  • Supervised the compliance of COVID-19 policies within the building

Data Clerk

Hardwood Designs
Hillsborough, NC
06.2020 - 08.2020
  • Streamlined data storage system to a cloud-based software
  • Facilitated weekly meetings with staff to update production data
  • Conducted software training sessions for all staff members

Education

Bachelor of Science - Mathematical Statistics

Wake Forest University
Winston-Salem, North Carolina
05.2021

Skills

  • Microsoft Suite
  • Salesforce
  • R
  • Java
  • SQL
  • Problem solving
  • Detail-oriented

Timeline

Study Data Specialist

Clinical Ink
06.2023 - Current

Validation Analyst

Clinical Ink
05.2021 - 06.2023

Data Clerk

Hardwood Designs
06.2020 - 08.2020

Office Assistant

Wake Forest University Department of Music
08.2019 - 05.2021

Bachelor of Science - Mathematical Statistics

Wake Forest University

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Courtney Craven