David Glavac

Experience

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  Bristol-Myers Squibb

  Sept 2003 - Jul 2008

  Information Systems Analyst
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  ICON plc

  Aug 2008 - Feb 2022

  Manage a team of Associate to Senior-Level Clinical System Designers and Clinical System Developers. Resourcing team leads, reviewing team members utilization, performance, project timelines, budget and scope of work. Performs interviews, on-boarding, training, and mentoring.Clinical System Development department liaison to Data Management Account Group Heads for multiple sponsors, responsible for resource and CSD quality escalations.Medidata Rave EDC Builder, Trainer, administrator (go-live/migrations, core configuration, End of Study Media process, FTP access), custom function programmer, subject matter expert. Actively work with the Medidata PMs to discuss ongoing support tickets and escalations, evaluation/notification of system updates and releases, new URL setup, and manage the internal Rave Admin team to ensure support to the wider ICON DM and CSD team.DataLabs EDC build and Web Services Integration SME. Support database migrations at the admin level. Work with the business system owner, product manager, and study teams, providing technical and process support. Show less Managed associate-level Clinical System Designers and Developers. Mentor new associate-level hires.Successfully delivered multiple complex clinical database builds and protocol amendments (multi-arm, multi-phase, blinding; therapeutic areas: Oncology, Neurology, Immunology, Infectious Disease, Pain, ADHD and others) on time, prior to First Patient In. Reviewed and analyzed Clinical Trial Protocol, Schedule of Assessments, Providing technical input and solutions to the Lead Data Manager, Sponsor, Clinical System Designer on database / eCRF design. Review Timelines/scope of work. Programming dynamic and edit check functionality in the CDMS (Medidata Rave / Custom Functions, DataLabs, ODM integrations), Third-Party Vendor Data imports and Data Transfer Specifications (SQL/SAS), Programming Custom Reports/Programs, Vendor Reconciliation, CRF data validation outputs (SQL, JReview)Medidata Rave EDC Builder, Trainer, administrator (go-live/migrations, core configuration), custom function programmer, subject matter expert. DataLabs EDC build and Web Services Integration SME. Show less Developed and went live on multiple clinical database builds. Reviewing Clinical Trial Protocol, Schedule of Assessments, Providing technical input to the Lead Data Manager, Sponsor, Clinical System Designer on database design. Review Timelines/scope of work. Programming dynamic and edit check functionality in the CDMS (Medidata Rave / Custom Functions, DataLabs, ODM integrations), Third-Party Vendor Data imports and Data Transfer Specifications (SQL/SAS), Programming Custom Reports/Programs, Vendor Reconciliation, CRF data validation outputs (SQL, JReview)Medidata Rave EDC custom function programmer subject matter expert. DataLabs EDC build and Web Services Integration SME. Show less Assigned onto multiple clinical database builds. Reviewing Clinical Trial Protocol, Schedule of Assessments, Providing technical input to the Lead Data Manager, Sponsor, Clinical System Designer on database design. Review Timelines/scope of work. Programming dynamic and edit check functionality in the CDMS (Medidata Rave, DataLabs, Oracle Clinical), Third-Party Vendor Data imports and Data Transfer Specifications (SQL/SAS), Programming Custom Reports/Programs, Vendor Reconciliation, CRF data validation outputs (SQL, JReview)Medidata Rave EDC custom function programmer subject matter expert. DataLabs EDC build SME. Show less

  • Manager, Clinical Systems

    Oct 2020 - Feb 2022

  • Principal Clinical System Developer

    Jul 2017 - Sept 2020

  • Senior Clinical Systems Developer

    Mar 2012 - Jun 2017

  • Database Programmer II

    May 2010 - Mar 2012

  • Database Programmer

    Aug 2008 - May 2010
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  Everest Clinical Research

  Feb 2022 - now

  Manager, Clinical Database Design