David Kozlowski

Experience

• 

  Biomedical Systems

  Jan 2003 - Jan 2019

  (Acquired by ERT in 2017)- Project Leader for enterprise level infrastructure software to support ECG clinical trials in a paperless and single source system. This includes Business Analyst, Project Management, Architect and Validation Lead responsibilities. - Manages a dedicated team including developers and validation specialists- Acts as primary application-level DBA for production applications - Acts as a senior SQL developer on enterprise and smaller applications for Cardiac related clinical trial applications. - Supports business units to determine alternatives for the overall operating strategy and business architecture. Identifies and assesses viability (technical, cost, and resources) of alternatives in conjunction with business and executive management teams.- Primary Contact for ECG Warehouse submissions to the FDA.- Supports MCC Metrics reporting.- Working knowledge with multiple Clinical ECG, Holter, and ABP platforms. - Collaborates with developers and subject matter experts to establish the technical vision and analyze trade-offs between usability and performance needs.- Designs critical system components that impacts the overall enterprise architecture.- Offers technical project management and mentoring to development teams when required.- Participates in and manage responses to Sponsor audits. - Author S.O.P's and guidance documents.- Maintain role as primary system administrator for Data Management related systems.- Provide training, guidance, and mentoring on Clinical Data Management and Clinical Trial related activities. Show less - Develop & implement standards, processes, and procedures for software development.- Lead software development efforts throughout entire SDLC processes.- Managed and Lead 10 medium & large scale projects concurrently.- Authored S.O.P's and guidance documents.- Act as Business Analyst, Architect, and Project Manager roles when necessary- Coordinated across business units and development teams to identify & implement solutions.- Maintained role as Data Management oversight and primary contact for ECG Warehouse submissions.- Maintained role as primary system administrator for Data Management related systems. Show less - Managed international team of data managers and software developers (15 - 30 staff) on a daily basis.- Provided training, management, and oversight for Clinical Data Management practices across all Biomedical Systems business units, including defining best practices for department.- Primary point of contact for electronic submissions to ECG Warehouse as part of broader FDA regulatory submissions. This includes efforts related to certification for Biomedical Systems.- Facilitated and fostered client relationships as part of Business Development activities.- Authored S.O.P's and guidance documents.- Coordinated Quality Control and Data Analysis activities.- Assisted with statistical and consulting services in conjunction with Scientific Affairs team, including Chief Medical and Chief Scientific Officers.- Served as Technical Lead and Analyst for all medium & large scale development activities based out of St. Louis headquarters.- Acted as Senior Business Analyst for Data Management & Application Development tasks related to Corporate, Pharmaceutical, and Imaging related clinical trials.- Primary system's administrator for applications produced or supported by department. Show less

  • Solutions Architect

    Apr 2012 - Jan 2019

  • Technical Lead

    Jan 2011 - Apr 2012

  • Assistant Director, Data Management & Application Development

    Jan 2005 - Jan 2011

  • Data Manager

    Jan 2004 - Jan 2005

  • Data Analyst

    Jan 2003 - Jan 2004
• 

  Clario

  Jan 2019 - now

  • Lead Business Analyst team for all business lines and cross-functional areas within R&D• Coordinate with and support the ERT Architecture teams in defining and aligning business and enterprise architecture• Manage the development of Domain models for all functional areas• Collaborate with Sr. Directors, Executive Management and relevant stakeholders to define the technical/management strategies and budgets necessary to sustain both existing software products and to develop new product initiatives• Participate as a member of the Engineering (R&D) senior management team and corporate management teams to define strategies, goals, and provide oversight to R&D and Product Management activities. Show less • Lead and manage R&D development teams for Cardiac and Respiratory product development• Mentor and lead engineering teams through processes for product architecture, software development, software quality testing, release management• Collaborate with upper management and relevant stakeholders, define the technical/management strategies and budgets necessary to sustain existing software products and to develop new product initiatives• Participate as a member of the engineering senior management team and corporate management teams to define strategy and goals• Act as Architect, Developer, and Tester as necessary Show less

  • Senior Director, R&D

    Jan 2023 - now

  • Director of Business Analysis (R&D)

    Sept 2021 - Feb 2023

  • Director, Software Development (R&D)

    Mar 2020 - Aug 2021

  • Principal Engineer, R&D

    Jan 2019 - Mar 2020