Bob Baldwin Email & Phone Number

Durham, Nc

Provided technical leadership on choosing best practices and project data flows for data management processes, including data integration models and methods throughout the lifecycle of multiple clinical trials.  Take lead role in data team. Primary responsibility for clinical events technical and data deliverables. Oversee, provide guidance, and delegate tasks as needed for multiple clinical trial projects. Performed requirements to test case mapping, user acceptance testing and move to production for DCRI’s first electronic adjudication platform based on the SharePoint platform. Performed user acceptance testing and migration of multiple mega-trial projects to web based adjudication platform.

Durham, Nc

 Created, reviewed and executed validation documents and protocols – IQ, OQ, PQ, User Requirements, Test Cases, Traceability Matrix and Summary Reports. Technical support for system and software validations, in accordance with FDA Quality Systems Regulation - 21 CFR Parts 11 and 820. Perform internal audits of validation documents to insure readiness for any FDA inspections

Research Triangle Park, Nc

 Developed and implemented a metrics and reporting system to track environmental compliance (RoHS) for server and consumer brands – using various tracking and reporting databases. Managed feature planning, user acceptance testing and upgrade deployment of software tools required for environmental compliance tracking and measurement.

Durham, Nc

 Owned and operated a 10 unit salon and managed four employees. Obtained 900 new clients during the first six months of operation.

Hillsborough, Nc

 Contracted to provide overall operation of a convenience store / service station. Increased average daily inside sales by 25% and daily fuel sales by 15% over previous yearly period.

Research Triangle Park, Nc

 Managed project startup, maintenance and completion for multiple telecommunications equipment projects using VM/CMS Rexx based mainframe databases. Managed the daily engineering activities for a team of 15 engineers Coordinated the training and development requirements for 120 engineers Developed and implemented a root cause analysis process. Initiated corrective action for top five errors and reduced occurrence by 90%. Facilitated defect prevention team, identifying process improvements resulting in savings of over 250K per year. Developed fast implementation process for ISDN hardware, reducing deployment interval from 12 weeks to 2 weeks.

Customer application engineering for broadband and microwave telecommunications equipment.

Management Information Systems

Associate, Electronics Technology