SUMMARY

• Over 25 years’ experience with medical research and laboratory data programming and management.
• More than 15 years working with multi - disciplinary medical research teams.
• Experienced data manager and analyst/programmer (SQL Server T-SQL, SSMS, and SSIS).
• Exposure to EDC systems (Bioclinica Express, and REDCap)
• Exposure to laboratory information management systems (Soft LIS, STARLiMS, Labware)
• Experience with laboratory data integration (Mirth Data Integration Engine - HL7).
• Advanced user of MS Access (Table, Form and Macro Design, VBA, Access and Pass-Through SQL).
• Confident user of Microsoft Office applications (Access, Excel, Outlook, PowerPoint, Word, Visio).
• Experience with SAS, STATA and SPSS.
• Training in C, COBOL, Flex, HTML, Java, Pascal, Oracle PL/SQL, Together, UML, VB.

PROFESSIONAL EXPERIENCE

Confidential, Rockville, MD

Clinical Research Database Administrator

Responsibilities:

• Manage the installation and build-out of the laboratory information management system (STARLiMS).
• Manage the installation and build-out of an EDC system for clinical trials management (REDCap).
• Establish the infrastructure to support centralized data stores (SQL 2012), to house tabulated research and analytic data.
• Establish the ETL processes (SSIS), to interface and integrate bio-repository and laboratory data.
• Work with research teams to implement data management and work-flow process improvement.
• Provide information technology project management support (Smartsheet, Visio).
• Assist in development of standard operating procedures (SOPs).
• Improve data harmonization and enhance data quality, to support analytics and modeling.
• Helping to improve compliance with 21CFR11 and military policies in a highly regulated environment.
• Assist Administrative Director with information technology budget.

Confidential, Jacksonville, FL

Senior Data Manager/Programmer

Responsibilities:

• Developed and maintained a repository for medical device clinical research data (SQL 2008r2), implementing the CDISC Study Data Tabulation Model (SDTM).
• Integrated EDC (Bioclinica Express) and optometric instrument data into the data model, developing procedures to load and perform data quality checks (T-SQL and SSIS).
• Managed and coordinated the data flow process with external vendors.
• Directly engaged study teams (clinician, CRM, CRA, CDM, biostatisticians), throughout the study life-cycle (protocol development, time and event analysis, CRF review, data management, interim reads, study closeout, data analysis), to produce well curated and timely results.
• Developed custom programs to restructure marketing and survey data for down-stream analysis.
• Prepared custom tables, listings and forms (TLFs), for analysis of data masked to biostatisticians.
• Incorporated compliance measures and process enhancements to improve data harmonization and metrics in this regulated environment.

Confidential, Rochester, NY

Senior Interface/Systems Analyst

Responsibilities:

• Assisted consultant team in developing interfaces to external systems from a new laboratory information management system (Labware LIMS).
• Provided maintenance programming support and troubleshooting for custom interfaces (VB, T-SQL).
• Developed and maintained custom interfaces (Mirth Integration Engine) and ETL programs (VB, T-SQL, SSIS), to integrate external laboratory result data (HL7), into the clinical trials management system.
• Prepared requirements, specifications and technical documentation for data integration projects.
• Prepared complex T-SQL procedures, functions, views, indexes, triggers, and jobs to support data extracts, audit trails and reporting.
• Provided basic administrative support (roles, logins, and permissions, database backups/restores, diagnose blocking issues, etc.), for SQL 2005 and 2008 databases
• Established linked servers to support distributed database querying between the SQL transaction system and the Oracle-based laboratory information system (Soft LIS).
• Established and maintained log shipping to support database replication (SQL).
• Provided custom databases and data management services in support of clinical trials - incorporating the LAB 101 and SDTM LB Domain models (CDISC, MS Access, SAS, SQL).
• Developed databases and ETL processes to support data extracts (MS Access, SQL, SAS), and custom reporting to pharmaceutical sponsors (Crystal Reports, SSIS, SSRS, SAS).
• Main ETL developer for laboratory data repository, incorporating data from central laboratories, worldwide (SQL Agent, T-SQL, SSIS).
• Primary developer of processes used to automate data management for the Clinical Trials Division (SQL Agent, SSIS, T-SQL, MS Access).
• Developed processes to transfer and report laboratory result data to partner laboratory (T-SQL, SSRS).
• Reworked stored procedures (primarily dynamic SQL) and developed proper indexing to dramatically improve loading time and reduce timeouts for queries from ACM’s Labstar web reporting portal.
• Provided direct support to clinical project managers, clinical research associates, and management team.
• Provided training and mentoring to junior data management staff.

Confidential, Tampa, FL

Clinical Data Analyst

Responsibilities:

• Implemented a new hospital-wide online occurrence reporting system (SoftMed/3M).
• Researched occurrence reporting with departmental subject matter experts throughout the hospital.
• Designed/built user interfaces, work lists and custom reports.
• Created a custom client to enable Risk Management staff to easily query and report from the underlying database (SQL, MS Access).
• Provided on-demand reporting of over 100 combinations of both summary and detailed information, from a simple reporting matrix (VBA, MS Access SQL, T-SQL).
• Provided technical support for end-of-year regulatory reporting.
• Extracted incident report data from retired system and new system.
• Mapped and harmonized the data from two disparate systems.
• Created custom reports to meet ACHA requirements.

Confidential, Rochester, NY

Lead Analyst/Programmer

Responsibilities:

• Provided programming and database development to support health services research (MS Access, SAS).
• Involved in all phases of research projects - preparation of protocols, drafting data collection instruments, creating data entry systems, preparing analytic datasets, and data analysis (MS Access).
• Worked with statisticians, physicians, and analysts locally and from other universities, to prepare data for CDC sponsored vaccine surveillance studies (New Vaccine Surveillance Network - NVSN).
• Managed and restructured data from surveys, chart reviews, laboratory tests, billing systems and health insurance claims (MS Access, SAS, STATA).
• Supervised staff of two to six people depending on the research projects in progress.
• Primary programming and data analysis support for medical research grants, the Pediatric Practice, and a community-based immunization outreach program for Monroe County (MS Access, SAS).
• Developed and maintained databases (MS Access, FoxPro, SAS).
• Provided training and consultation to medical staff on use of PC’s and Microsoft Office software.
• Fully responsible for data collection, database design, analysis and creation of charts, graphs and mappings of chart review data.