Todd Lewis

Experience

• 

  Long Island University

  Jan 1990 - Dec 1995

  Network Administrator

  - Managed Novell LAN for university performing arts center. - Oversaw transition from dumb-terminal, leased VAX-based environment to in-house, PC-based LAN. - Supported automated box office ticketing and fundraising software. - Introduced and developed systems and processes for automated generation of season tickets, season ticket invoices, sales confirmations and real-time telephone sales.

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  Pharmacia & Upjohn

  Feb 1997 - Nov 1997

  Biostatistics and Reporting Analyst

  - Authored Windows VisualHelp files for automated output display generation system.

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  Pharmacia Corporation

  Nov 1998 - Dec 2003

  Clinical Systems Analyst

  - Build clinical studies in Oracle Clinical (OC). - Authored validation documentation and led validation effort for OC add-on systems for medical event and drug dictionary coding and for laboratory assay processing. - Collaborated on laboratory assay system that performs normal range and CTC grade assignment as well as unit conversion functions to work in conjunction with OC. - Provide daily OC and database support worldwide to Clinical Systems Analysts, Data Managers and Biostatistics units. - Serve as primary point of contact with Oracle support and development to resolve technical issues escalated to me by CSAs and other users. - Instrumental in upgrade of OC from version 3.1.1. to 4.0.2 - Manage laboratory assay library. - Co-manage medical event and drug coding dictionaries and autocoding systems, with dictionaries including MedDRA, WHODRUG, WHOART, COSTART and SUDDS. - Served as Site Administrator for the Kalamazoo Medical Development site, which entails creation and maintenance OC and Integrated Review user accounts for internal and CRO personnel, as well as interaction with IT for creation and maintenance of UNIX and Citrix MetaFrame accounts. - Prepare technical documentation for OC-related processes and other systems. - Serve as the Kalamazoo site representative to the Data Base Standards Group, which functions as the OC global librarian. - Serve on validation and implementation team for OC Thesaurus Management System (TMS) version 4.0.4 - Served on team to transition database operations work processes and standards to accommodate implementation of OC Remote Data Capture (RDC) version 3.2 Show less

• 

  Pfizer

  Dec 2003 - now

  Responsible for support of customers requiring data and reports from regulatory and safety systems within the Operations CoE, including the Pearl and Medical Data Cloud (MDC) databases.Work with business owners to help formulate requirements for various metric and data quality reports.Develop data sourcing queries in SQL for provision of data to other systems (Spotfire, ex.) for analysis.Develop complete report programs using SAS, including tracking, output distribution and scripted control of SAS running on Linux.Partner with business technology (BT) to develop solutions to reporting challenges concerning system access, permissions, file transfer technology, and tool selection. Show less - Promoted to Associate Director December 2013. - Serve as report development lead for the Pfizer Operational Data Warehouse (ODW). - Oversee the specification, development, testing and deployment of reports from ODW. - Develop reports in Oracle Business Intelligence (OBIEE) and other Oracle tools. - Work with business owners to discern optimal ODW reporting solutions. - Participate in the definition of operational metrics covering all aspects of clinical trial conduct. - Serve as subject matter expert for the ODW data model and for ODW operation. - Work in partnership with business technology (BT) and outside consultants to define the ODW data structures. - Serve on project teams with the goal of defining efficient and robust process flows for metrics specification and development, ODW report generation and other ODW-related processes. - Support legacy clinical data collection as an Oracle Clinical (OC) subject matter expert, including oversight of contracted OC programmers and participation in defining clinical data standards. Show less - Responsible for overseeing daily work of Functional Service Provider (FSP) personnel. Monitor FSP output, proficiency and productivity. - Manage Data Quality Specifications (DQS) process and instruments. - Responsible for training FSP staff, both and on-site and off-site (US and international), in areas of expertise (Oracle Clinical procedure programming and DQS). - Assist in preparing quarterly metrics for Study Start-up. - Collaborate on effective lab data handling for Oracle Clinical. - Oversee programming of OC procedures for all new Pfizer Data Standards (PDS) efficacy and core data standards, and participate in standards development for PDS as did formerly for GRADES. - Monitor and respond to GCDS Track issues in areas of expertise. - Support various Clinical Informatics and Innovation (CII) initiatives, such as MHRA Audit Response and Validation Procedure/Discrepancy Initiative. - Continue to develop new versions for and support PreFlight database QC application. - Program custom diagnostic reports for procedure and discrepancy monitoring. Show less - Responsible for interpreting protocol study designs, treatment schedules and statistician randomization specifications and configuring randomization parameters in Oracle Clinical. - Responsible for randomization breakblind activities. - Program and troubleshoot OC PL/SQL procedures, and manage maintenance of standard procedure library. - Responsible for furthering GRADES standards library development by acting as lead for newly developed OC Grades procedures, and for overseeing and revising the Data Verification Checks sections of new and existing DCDs. - Work closely with Clinical Data Standards department both in maintenance of legacy-Pharmacia standards, and collaboration on new DCD structures as they relate to Data Verification Checks. - Helped lead technical effort to interface P1MS Phase I clinical trial management system with OC for production of GRADS-compliant Treatment and other information. - Contribute actively to the development of refined processes and practices for developing the GRADES library; performing and documenting randomization activities; and for the functioning of SSU generally. - Sought out as a technical resource on a variety of subjects, particularly OC troubleshooting, research and generation of metrics and diagnostic reports, as well as requests for ad-hoc SQL and PL/SQL OC programming. Show less

  • Senior Information Manager

    May 2016 - now

  • Senior Information Manager

    May 2015 - Apr 2016

  • ODW Lead, Report Development (Associate Director)

    Jun 2013 - Apr 2015

  • Operational Support Manager

    Jan 2006 - May 2013

  • Clinical Systems Analyst II

    Dec 2003 - Dec 2005