Project Abstract:

For a major pharmaceutical company, designed, developed and implemented a Global Clinical Data Collection Repository. This was a tremendous task as not only culture issues were present, but also each country accomplished their needs using different tools.

The responsibility of our global project manager was to build and manage an IT project team from both a business and budget standpoint while keeping abreast of all FDA regulations and corporate internal SOP's. This project required significant international travel and involved the management of a 30 member project team and total budgetary responsibility. Our project manager spent upwards of 20 hours per week within the business communities worldwide researching issues and building a harmony between IS and the Clinical Data Management business. This approach allowed us to address any issues prior to delays while making the business community a partner in all decisions.

MICROSOFT PROJECT was used for all planning and budgeting. VISIO was used for mapping all data relationships while VISUAL BASIC and ORACLE were used as the programming development tools. ASP, and JAVA were the online components for the web-based solutions.