Cincinnati, Ohio, United States
Research database developer translating highly complex data system requirements into functional data collection tools for use in clinical and exploratory research. Adept at bridging the gap between a client’s business needs with the technical requirements needed for application development. Proficient in highly regulated environments requiring compliance with HIPAA, 21 CFR Part 11, and/or FISMA.
Cincinnati Children’s Medical Center - Data Management Center (DMC) • Technical Project Manager on the Longitudinal Pediatric Data Resource (LPDR) initiative of the national Newborn Screening Translational Research Network (NBSTRN) managing a team of developers tasked with creating tools to combine phenotypic and genomic data for exploratory purposes as well as harmonizing data across the network of projects. • Working collaboratively with data managers to build and test Medidata Rave databases used in multimillion dollar NIH funded projects such as the Bench to Bassinet project. • Lead programmer of all custom function development within Medidata Rave using C# and SQL. • Over 12 years of SAS program development utilizing web service of systems such as Medidata Rave and REDCap to pull data for cleaning, querying, or analysis. • Utilizing standards for cross-system communications such as CDISC ODM. • Development of change request plan for post-production database change requests leading to subject migrations or publishing of edit checks. • System administration and application support of Medidata Rave, REDCap and OpenClinica EDC systems. • Development of SOP educational materials for ongoing staff training and implementation of proper procedures.
• Spearheaded an initiative to implement the first 21 CFR Part 11 compliant data collection system used within the Hospital for research. • Developed and maintained multiple relational databases for use in investigator initiated clinical trials impacting thousands of subjects. • Drafted new SOPs outlining tasks such as the development of data management plans, QC/QA plans, and 21 CFR part 11 compliance documents. • Created and updated content for our department’s internal and external facing websites. • Created training material for databases, data transfers, and application specific tasks for end users. Setup a disaster recovery system for our department by purchasing the equipment need and developing the necessary scripts to carry out the tasks of back and logging.
• Developed SAS programs using macro processing to sort and track subject data. • Creation of paper and electronic forms within the Cardiff Teleform software for use within a clinical trial. Create and maintain relational Access databases combining multiple data sources in a multi-user environment and implementing security down to the field level.