About
I am a clinical trials data management specialist with over 12 years of experience. In this time I have implemented many high-value data management and reporting systems, using a wide range of technologies, working with diverse stakeholders.
In addition to technical expertise I have extensive domain knowledge of clinical research from working in coordination teams, developing components of research-specific software, and have completed a Master of Biostatistics.
I am interested in helping researchers efficiently collect accurate and complete data, and supporting both practicing clinicians and their patients in their decision-making processes through data systems, analysis, analytics, and visualisations.
I am motivated by the participants and clinical staff that collaborate to advance medical science through research.
Technical Skills
I am familiar with the following technologies.
- Programming languages:
- Expert: SQL, Python
- Advanced: PL/PGSQL, Stata, SAS, bash, VBA/VBScript, XSLT
- Intermediate: R, Clojure, powershell, PHP, JavaScript, Java, C#, C
- Database Systems:
- Expert: PostgreSQL
- Advanced: SQLite, MS Excel, MS Access
- Intermediate: Microsoft SQL Server, Oracle DBMS
- Other tools / systems:
- Development: Git, Intellij IDEA, Notepad++, vim
- OS/Environments: Linux (CentOS, Ubuntu), Docker, Windows (Server, Pro), Android
- Project Mgmt: Jira, GitHub, Trello, TFS, RStudio
My GitHub profile contains examples of projects where permission was given to share the code.
Clinical Trials Data Management Skills
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, Australian Privacy Principles, GDRP
- 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