Experience

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  Quintiles

  Sept 1998 - Jan 2005

  Clinical programmer

  • Served as Lead Programmer on project teams• Planned and coordinated clinical systems and databases through effective design, development, implementation, maintenance, user and client support• Enhanced quality and interpreted data through programming validations and ad hoc scripts and reports• Disseminated knowledge on various clinical data systems to colleagues

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  Inc research

  Jan 2005 - Jul 2008

  Sr. clinical programmer

  • Served as Lead Programmer on project teams for traditional and RDC studies• Performed as Thesaurus Management System (TMS) Administrator for INC, charged with staging, loading, & supporting industry standard and customized clinical coding systems used by Data Management & Drug Safety departments • Planned and coordinated clinical systems and databases through effective design, development, implementation, maintenance, user and client support• Mapped data exports from OC to SAS datasets for internal and external clients• Integrated externally supplied vendor data into clinical data systems• Served as database migration (OC 4.0.3 to 4.5.0) validation coordinator across multiple protocols • Member of the INC Strategic Solutions Group, providing guidance and solutions for the Global Library Committee• Member of the INC CDISC Implementation Strategy Team & initiated standardization practices, enhancing harmonization across DM and Statistics teams • Trained & mentored colleagues on OC development and maintenance activities Show less

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  Statworks

  Jul 2008 - Jul 2011

  Manager, clinical programming & data base adminstration at statworks, inc

  • Managed local team of clinical programmers• Implemented and maintained a new open-source EDC system across a number of Ph I and Ph II studies• Developed standard operating procedures and optimized processes for Data Management department, successfully guiding departmental practices away from ‘paper-based’ processes and into EDC realm• Led team that designed, ‎implemented, and validated a data management system‎ that automatically bridged an open-source EDC system (OpenClinica) with a commercial clinical coding application (Clintrial Classify), thereby leveraging existing functionality into a low-cost solution• Provided user account and database administration• Operationally evaluated & audited EDC & IWR/IM service providers in support of future vendor partnerships Show less

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  Pharm-olam international

  Jul 2011 - Jan 2017

  • Lead the implementation team within Data Management to incorporate new technologies and optimize Pharm-Olam processes and standard operating procedures. Efforts include full-spectrum of the implementation life-cycle, from user requirements draft, vendor operational assessment, qualification auditing, team training & accreditation, system launch, & SOP/process evaluation and tuning (Systems adopted include Merge eCOS & Medidata Rave.)• Created and renovated numerous key SOPs, including SOPs concerning data systems, validation, randomization, inventory management, reporting, & system administration • Developed and maintained industry-standard libraries (CDASH eCRF, SDTM-ready extractions) across multiple platforms to leverage efficiencies and promote quality deliverables• Evaluated, validated, and audited key data systems (EDC, IWR/IM, clinical coding, ePRO, and reporting service providers) to Pharm-Olam and industry standards• Promoted services in support of Business Development, from customer contact & outreach, quote generation & proposal content, to system demonstrations and bid defenses• Organized and delivered technical support for the operational aspects of data systems• Provided training, guidance, and support documentation for new systems Show less • Lead globally-distributed data systems and clinical programming team, coordinating activities and deliverables across six time zones in support of mission-critical activities• Developed standard operating procedures and optimized processes for EDC systems, randomization, inventory management, clinical trial development life-cycle, reporting, validation, and user acceptance testing• Managed he development of industry-standard libraries (CDASH eCRF, SDTM-ready extractions) to leverage efficiencies, promote quality deliverables, and harmonize elements between DM and Statistics• Evaluated, validated, and audited EDC & IWR/IM service providers• Promoted DM services in support of Business Development, including customer outreach and demonstrations• Provided user account and database administration Show less

  • Principal Data Systems Engineer

    Aug 2014 - Jan 2017

  • Manager, Data Systems

    Dec 2011 - Aug 2014

  • Senior Data Systems Designer

    Jul 2011 - Jan 2012
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  Duke clinical research institute

  Feb 2017 - now

  Program manager, technical services

  • Establish a Medidata Center of Excellence for the DCRI Data Solutions group• Serve as a project leader for projects, developing and maintaining complex projectplans• Coordinate all technical aspects of CDM projects, but not limited to databasedesign, development, QC/UAT, integration of data from third party sources, releaseto production, and project maintenance• Facilitate and manage communication between Data Management and projecttechnical resources• Manage development activities to project budgets and implements correctiveaction to maintain budget• Facilitate problem resolution and escalation of issuesacross projects or program• Analyze and propose best practices for clinical programming and data integrationprocesses• Educate internal and external partners on EDC and data integration activities• Participate in business development activities such as presentations to prospectivesponsors, development of scope of work and cost estimates• Participate in review and provides input in writing proposals and grantapplications• Oversee forecasting and resources for program area Show less