SUMMARY:

• 13 years of experience in the clinical research and trials industry utilizing the IWRS/IVRS technology. A total of 18 years experience in managing and developing computer systems. Demonstrated areas of accomplishment in:
• SQA Testing & Methodologies
• Test Plans, Cases & Processes Functional Requirements
• Scripting & Documentation
• Regression & Negative Testing
• UI & Compatibility Testing
• Data Interface & Migration Testing
• Performance/Load/Stress Testing
• Defect/Bug Tracking
• Test Strategies
• QA & QC Standards
• Knowledge of entire IWRS/IVRS Project Life Cycle
• IWRS/IVRS Requirements Specifications and Design Specifications
• Designing and testing of IWRS/IVRS or IRT systems
• Interfaces between IWRS/IVRS database and Clinical database, EDC, Lab and Supplies databases
• Supervision of IWRS/IVRS Development and Testing Team
• Designing complex IWRS/IVRS systems based on study Protocols
• Client meetings, Bid defenses presentations
• Constant interaction with Sponsors, Global Clinical Project Managers and Team Leads
• IWRS/IVRS Maintenance support tasks
• Working on multiple projects concurrently
• Completion of projects with tight timelines
• Focused on quality and designs which consider ease in study maintenance or conduct

PROFESSIONAL EXPERIENCE:

Project Manager

Confidential

• Planned, developed and administered software test plans to detect and diagnose errors and bugs for the company’s IWRS/IVRS product line.
• Performed regression, integration, platform and performance testing to certify the stability and usability of software systems.
• Developed and executed test scripts that helped improve accuracy of QA results.
• Provided comprehensive software release documentation and training to support staff after compiling validation test outcomes.
• Black Box and Gray Box testing for various projects: service packs, new functional modules and hot fixes.
• Performed extensive UI testing of the 4 major browsers (multiple versions) on Windows (multiple versions) and Mac OS utilizing virtual machines.
• Documented clear and accurate bug reports and delivered clear status updates for testing areas in a timely manner.
• Comfortable taking ownership for the testing of a product or areas within a product providing feedback to both development teams and project/product management teams.
• Validated complex data transfer projects relaying on replicating production data to make it available for reporting and/or transfers. This validation covered the extraction of production data into the staged database, the processing of the extracted data into groups of defined entities (creating the sequence XML files, zipping them and encrypting data for transmission) and the transmission via Web - Services calls.
• Employed a “test-to-break” approach on testing initiatives and clarified ambiguous requirements to ensure the effectiveness of all test plans.
• Improved the documentation of testing practices to enhance their repeatability, saving time and money and encouraging testing standardization and best practices.

Design Project Manager

Confidential

• Created/designed base systems used by the company to build multiple studies or program level studies for major clients.
• Can do both client facing and technical roles as recognized by Management.
• Continued to be given or assigned with the complex studies to design the systems.
• Created template specifications and UAT scripts to help the company in future projects.
• Received company awards for assigned complex studies.
• Supported R&D on base system questions and suggested improvements to the system.
• Designed multiple Interfaces/Data Transfers with EDC, Supplies and Simulation groups and provides expertise to company on similar needs.
• Mentored and trained Design Project Managers and Associate Project Managers.
• Supported or advised our Technical Operations on complex requirements.

Project Manager

Confidential

• Attended Investigator Meetings or WebEx presentations to train the system users.
• First project is a complex study with multiple stratifications and multiple interfaces.
• Set up manual randomization procedures for the client and provide expertise to company for similar needs.
• Assigned with the complex studies by the Management.
• Performed extensive study maintenance work (new accounts, new sites, drug management).
• Executed Study Change Requests when needed.

Senior Analyst

Confidential

• Software Development Life Cycle: analyzed, designed, coded, tested and implemented IVR applications for clinical trials (InVision, Oracle). This was between May and September while phasing out the Confidential IVRS platform (Cenduit being a joint venture Confidential - Fisher).

Confidential, Morrisville, NC

Computer System Analyst / Senior Analyst

• Designed IVR applications for a Intervoice - Oracle - Cold Fusion environment
• Software Development Life Cycle: analyzed, designed, coded, tested and implemented IVR applications for clinical trials (InVision, Oracle).
• Coded IVR applications using InVision, Speech Recognition and VoiceXML for the IVR, SQR for the reports and PL/SQL for the database
• Wrote IVR and Report Unit Test Plans, Database Operational Qualification Plans, Web Operational Qualification Plans, and IVR Installation Qualification Plans
• Coordinated the execution of the UT, OQ and Web OQ test plans

Confidential, Toronto, ON

Consultant

• ACD Prompt Response Integration (APRI), ANI / DNIS capture, digit collection, CTI gateways, call transferring and queuing (PBX <-> IVR).
• Developed an IVR application for ACCPAC International Call Centre in Vancouver. Integrated the IVR application with two SQL 7 servers, Siemens Hicom 300 PBX to transfer the calls and display info on agent’s phone display and a Resume Router to display info on agent’s monitor display.
• Configured and installed a five node telephony network for Greyhound Canada with IVR’s in Toronto, Calgary, Edmonton, Winnipeg and Vancouver and an administration system in Calgary using InterVoice boards and software.

• Developed VC++ and VB DLL’s to integrate IVR applications.
• Developed a web-based management reporting project using SQL, Access and ASP.

TECHNICAL SKILLS:

Languages: InVision, SQL, PL/SQL, C++, Visual Basic, SQR, Java, XML, HTML, C#

RDBMS: Oracle, MS SQL, DB2, Sybase, dBase

Tools: InVision, Toad, Quest SQL Navigator, SQL*Loader, ODBC, Remedy, Crystal Reports, Microsoft Visual SourceSafe, Merant PVCS, Merant Version Manager, Lotus Notes, Cenduit IRT (CIRT)

OS: Windows, UNIX