Jo Steele Email & Phone Number

• Responsible for all aspects of data management for a Phase 3b Clinical Trial. From protocol review, EDC selection, CRF design, DMP, SDTM, CDMS, clean data transfers, database lock and liaising with study statisticians. • Getting the database cleaned and locked on schedule, in 15 working days from LPLV.• As the senior staff member, advised the project manager in all areas of the study, and directed and instructed the CRA team.• Designed CRFs for the clinical trial in OpenClinica. Liaising with the sponsor, to meet their specifications, and ensuring the CRFs were simple to use, to reduce errors.• Coordinated with CDISC SDTM and ADaMs programmer and generated CDMS data extracts for sponsor.• Supervised and mentored junior staff in design of Investigator Initiated Studies CRFs.• Consulted on protocol development, so that studies were designed to gather data efficiently and to GCP and IG standards.• Wrote and edited SOPs for Data Management and areas of IT.

Virginia Beach, Virginia

• Specialized in Genetic research projects.• Converted raw genotypical data into formats suitable for analysis; performed standard and custom analysis procedures.• Devised comprehensive data management systems, from the design of questionnaires to analysis. These systems allowed the Principle Investigators to achieve their study data goals while minimizing the need for staff training.• Designed and programmed database applications for single-site and multi-site collaborative studies.• Trained clients in data management and database usage.• Wrote custom programs in PERL, ObjectPal, and R.• Performed standard genetic analyses using Plink, R, mach2qtl, Gene Hunter Plus, Cocaphase, TDTPhase, FBat, Merlin, Mega2.• Imputed unknown genotypes using the MACH, and Beagle software programs.• Managed data in MS Access and Corel Paradox.• Provided services for the following major clients: National Institues of Health/National Institute of Mental Heath, Cold Spring Harbor Labatories, Johns Hopkins University, University of Chicago, and Cleveland Clinic Foundation.

• Combined genome-wide phenotype (“Phenome”) data from six mental health diagnositic interviews (DIGS 1-4, GenRed, SADS-L) into a unified database. The total dataset contained approximately 15,000 subjects times 1,200 data points. • Imputed large sets of genotype data using the software programs Beagle and Mach. Was in charge of matching the orientation and ensuring the adherence to exact data formats.• Combined clinical and genome-wide association study (“GWAS”) data from multiple platforms and sites.• Formatted Next Generation Sequencing (in this case, “Exome”) data for analysis and combined it with GWAS data.• Designed and implemented a single-nucleotide polymorphism (SNP) database, cabable of handling data from multiple platforms, multiple stand directiosns, and thousands of subjects.

Baltimore, Maryland Area

• Managed a complex database system for a genetic study of families, including aspects of security, integrity and the usability of the data through a networked system.• Updated the data storage system from spreadsheets containing just the vital interview data to an inter-related database application maintaining all facets of the study. This led to increased data quality. Additionally, the new format facilitated analysis by integrating clinical data, DNA and Cell Line storage data, and genetic analysis results.• Wrote programs to check the logic of the data, which resulted in an error rate that was less than half the industry standard.• Produced data files for analysis, saving the investigators time and insuring correct data retrieval.• Worked as the site coordinator for a multi-site research study. This task comprised liaising with the other site coordinators, an external data management company and NIMH staff. Coordinated with the data management company to help users access their systems, retrieve the raw data from the other sites and resolve problems. • On a subsequent study, was the data liaison for the new design of a 150-page interview. Then designed the databases systems for the multi-site study, and oversaw its implementation at the other sites.• Streamlined many aspects of analysis by designing automated procedures to display the data in visual formats, particularly pedigrees and haplotypes. This led to strongly improved accuracy compared to the manual methods and saved a lot of time for the research teams.