Ivan Mitkov

Experience

• 

  Institute or Biodiversity and Ecosystem Research, Bulgarian Academy of Sciences

  Jun 2015 - Jun 2016

  Molecular Biologist

  Evolutionary Molecular Biology Research Group

• 

  National Specialized Hospital for Active Treatment of Hematological Diseases

  Jul 2016 - Nov 2017

  Medical Laboratory Assistant

  Laboratory of Hematopathology and Immunology - Flow Cytometry Section;Biobank Department

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  Tissue Bank Bioregeneration

  Nov 2017 - Jun 2018

  Biologist

  Tissue & Cell Processing Department

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  National Specialized Hospital for Active Treatment of Hematological Diseases

  Jul 2018 - Dec 2020

  Microbiology Laboratory Microbiology Laboratory Hematopoietic Stem Cell Processing & Cryopreservation Department

  • Laboratory Manager

    Jul 2020 - Dec 2020

  • Biologist

    Jun 2019 - Dec 2020

  • Biologist

    Jul 2018 - Jun 2019
• 

  Premier Research

  Jan 2021 - Jul 2024

  Senior Data Coordinator in the Clinical Data Sciences Department. Main responsibilities:· Prepares documentation, such as CCGs, DMP, DRS, ECS, External Data Transfer Specs, etc., with minimum oversight· Assists in developing standard test data for testing screens and listings and provides feedback on the results of the testing· Performs UAT on studies, including testing of edit checks, etc.· Assists in maintaining DBs and supports DB updates· Reviews CRFs, data listings, and DBs to ensure all data captured follow protocol, CCGs, DMP, etc.· Generates queries to appropriate internal or external personnel to resolve problematic data· Reviews responses to queries and resolves discrepancies· Performs external data and/or serious adverse event reconciliation, likely for mid-to-high complexity studies, indications, or vendor data types· Acts as a Lead Data Coordinator and/or Safety Reviewer on multiple studies. May oversee multiple studies on a portfolio to ensure consistency and efficiency.· Performs document submission to TMF· Supports TMF QC activities; may serve as the primary resource for this activity· Performs DB QC activities· Performs QC of study reports, eCRF PDF files· Supports the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status· Acts as back-up to Lead Data Scientist (LDS), as required, including activities related to DB set-up· Interacts with the LDS and other project team members on a frequent basis and may have direct client interaction· Ensures all tasks are coordinated and completed as per study plans and timelines· Is involved in training and mentoring of newer DC team members and presents appropriate training sessions· Serves as a subject matter expert, e.g. EDC system, specific DC tasks to support the wider DC team, etc.· May review and contribute to the development and/or update of department standard operating procedures and working guidelines Show less Data Coordinator in the Clinical Data Sciences Department. Main responsibilities:• Preparing documentation, such as CCGs, Data Management Plan (DMP), Data Report Specifications, External Data Transfer Specifications, etc.• Assisting in developing standard test data for testing screens and listings and provides feedback on the results of the testing• Performing user acceptance testing on studies, including testing of edit checks, etc.• Assisting in maintaining DBs and supports DB updates• Tracking CRFs• Performing data entry• Generating reports for data review• Reviewing CRFs, data listings to ensure all data captured follow protocol, CCGs, DMP, etc.• Generating queries• Reviewing responses to queries and resolves discrepancies• Performing external data reconciliation• Acting as a Lead Data Coordinator on two studies• Acting as a backup Data Coordinator on various studies• Performing document submission to Trial Master File (TMF)• Supporting TMF Quality Control (QC) activities• Performing database QC activities• Performing QC of study reports, CRF archive files• Supporting the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status Show less Associate Data Coordinator in the Clinical Data Sciences Department. Main responsibilities:• Assisting in the preparation of documentation, such as CCGs, DMP, Data Report Specifications, External Data Transfer Specifications, etc.• Supporting UAT on studies, including testing of edit checks, etc.• Assisting in maintaining databases and supporting DB updates• Tracking CRFs• Performing data entry• Generating reports for data review• Reviewing CRFs and data listings to ensure all data captured follow protocol, CCGs, DMP, etc.• Generating queries• Reviewing responses to queries and resolves discrepancies• Performing external data reconciliation• Acting as a Lead Data Coordinator to two studies• Acting as a backup Data Coordinator on various studies• Assisting document submission to Trial Master File (TMF)• Supporting TMF Quality Control (QC) activities• Supporting database QC activities• Assisting in QC of study reports, CRF archive files• Supporting the Data Scientist and/or PM in reporting financial project stats, study metrics, dashboard updates, project status Show less

  • Senior Data Coordinator

    Apr 2024 - Jul 2024

  • Data Coordinator

    Feb 2022 - Mar 2024

  • Associate Data Coordinator

    Jan 2021 - Feb 2022
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  COMAC MEDICAL

  Jul 2024 - now

  Clinical Data Manager