Table of Contents

1 Contact Details

2 Summary

I am a clinical trials data management (CTDM) specialist. I have 9.5 years' experience, spanning the trial data lifecycle:

In addition, I have a strong technical skills with applications programming, analytics and visualisation tools, IT system administration, and security standards. This experience spans a range of modern computing environments, including cloud / virtual servers, desktop PCs, and mobile tablets and phones.

I aim to promote adoption of best practice CTDM through the delivery of pragmatic, high quality, and compliant solutions that enable users to efficiently meet their objectives. My broad range of experience facilitates effective engagement with diverse stakeholders to ensure that both the technical and functional aspects of these solutions are optimised.

3 Skills

3.1 Clinical Trials Data Management

I am familiar with the following compliance aspects of trials:

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

3.2 Technical

I am familiar with the following technologies.

My GitHub profile (see Contact Details) contains examples of projects where permission was given to share the code.

3.3 Projects

The following are projects where the above skills were employed.

3.3.1 Mobile Data Collection

I designed and implemented a mobile data collection framework that improved quality and completeness of participant questionnaire data for 5 projects conducted by the VHCRP team at the Kirby Institute.

The framework covered all aspects - policies for device procurement, configuration, management, account management and security; tools for form design, validation, multi-language capable presentation customisation; procedures for data collection, submission, and storage; tools for ETL of collected data for analysis in Stata.

The deployment included 83 Android tablets for offline data collection at study sites, including hospitals, clinics and prisons in Australia and internationally, with thousands of responses from hundreds of participants had been collected and processed. At the centre of the framework was ODK Collect, an Android app for processing XML-based form definitions. Design and data processing tools included custom distributable desktop apps written in Python.

3.3.2 OpenClinica Community DataMart

I designed and implemented an ETL and reporting system that streamlined reporting and analysis workflows for 13 projects conducted by the VHCRP team at the Kirby Institute.

This system replaced a time-intensive process with numerous manual steps, with a robust, automated process that integrated with existing reporting and analysis tools while maintaining a high level of security and ease of use.

This system was implemented with PostgreSQL using SQL, PL/PGSQL, and Python. The ETL system involved transforming a column-based data storage format into user-friendly tables corresponding to the original form design templates uploaded to OpenClinica.

The deployment included encrypted connections between database servers and with client machines, data access controls mirroring those in OpenClinica, and integrated Windows domain authentication. Client tools were also developed to integrate via ODBC with Stata, SAS and Microsoft Access; as well as automated VBScript tools to simplify setup for new users. The preparation of detailed documentation and delivery of targeted training encouraged adoption of the system across the team.

3.3.3 System Integrations

I designed and implemented the following system integrations for the VHCRP team at the Kirby Institute:

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4 Employment

4.1 OpenClinica LLC: Solutions Engineer

4.1.1 Key Responsibilities

4.2 Cancer Institute NSW: Systems Analyst / Architect

4.2.1 Key Responsibilities

4.3 OpenClinica LLC: Solutions Engineer

4.3.1 Key Responsibilities

4.4 UNSW Australia: Clinical Trials Database Developer

4.4.1 Key Responsibilities

4.4.2 Achievements

4.5 University of Sydney: Clinical Data Coordinator

4.5.1 Key Responsibilities

4.5.2 Achievements

4.6 University of Sydney: Trial Coordinator / Data Manager

4.6.1 Key Responsibilities

4.6.2 Achievements

4.7 University of Sydney: Clinical Trials Assistant / Data Manager

4.7.1 Key Responsibilities

4.7.2 Achievements

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5 Education

5.1 Master of Biostatistics

5.1.1 Subjects

5.2 Bachelor of Science

5.2.1 Subjects

5.3 Short Courses

6 Presentations

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