About

I am a clinical trials data management specialist with over 10 years of experience. In this time I have:

  • Worked with and coordinated numerous multi-centre oncology clinical research studies,
  • Developed a variety of data collection and validation systems for clinical research,
  • Implemented sophisticated data processing and reporting tools, projects, and systems.

Looking forward, I am studying a Master of Biostatistics to further broaden the range of solutions and advice I can offer.

I am motivated by the dedicated medical professionals and participants that collaborate to advance medical science through research.

I am interested in helping researchers efficiently collect accurate and complete data, and to support their decision-making processes.

Skills

Clinical Trials Data Management

I am familiar with the following compliance aspects of trials:

  • Ethics and regulatory requirements including the TGA guidance on ICH GCP, the NHMRC National Statement, and Australian Privacy Principles
  • Standard regulatory forms including NEAF, SSA, CTN, and CIOMS SAE reports
  • Essential documents preparation from start-up to close-out in Australian and international trials in collaboration with hospitals, academic institutions, CROs, and pharmaceutical companies
  • Project management, site initiations, and delivering training for protocols and data systems
  • Design and implementation of data management plans, validation rules, interim analysis cleaning and centralised monitoring of key source documents
  • Development of documentation, procedures and operational frameworks for data systems development, data management workflows and data governance

I am familiar with the following off-the-shelf data systems useful for trials:

  • Systems collecting and managing clinical trial data: OpenClinica, InForm, RedCap, ClinTrial
  • Survey tools: ODK Collect, Enketo, LimeSurvey, SurveyMonkey
  • Others:
    • TeleForm: an Optical Character Recognition tool for digitising paper form data
    • LabKey: a system for laboratory sample management and annotation

Technical

I am familiar with the following technologies.

  • Programming languages:
    • Advanced: SQL, Python, PL/PGSQL, Stata, VBA/VBScript, and XSLT
    • Intermediate: PHP, JavaScript, SAS, Powershell/CMD, R, Java, and C#
  • Environments:
    • Advanced: Windows, Centos, Windows Server, Android 4.4 and up
    • Intermediate: Ubuntu, Docker, Google Suite for Education
  • Other (Advanced): Microsoft Access, Microsoft Excel
  • Servers:
    • Advanced: PostgreSQL 8.4 and up
    • Intermediate: Microsoft SQL Server 2012, Apache 2.4, Tomcat 6 and up, Nginx, CherryPy
  • Development tools: Git, Intellij IDEA, Notepad++, Trello, TFS, SSMS, RStudio

My GitHub profile contains examples of projects where permission was given to share the code.