Experience

• 

  Wygodnadieta.pl

  Nov 2011 - Nov 2015

  • Deputy Manager of Sales Department

    Nov 2013 - Nov 2015

  • Nutritionist - Customer Service Specialist

    Nov 2011 - Oct 2013
• 

  Kcr

  Dec 2015 - Feb 2017

  • Prepared, tracked and managed essential study documentation • Maintained the Trial Master File • Provided Site staffs with proper documentation, supplies and materials within the established timeliness • Actively supported preparation of submission packages to Ethics Committees and Regulatory Authorities • Prepared, tracked and managed essential study documentation • Maintained the Trial Master File • Provided Site staffs with proper documentation, supplies and materials within the established timeliness • Actively supported preparation of submission packages to Ethics Committees and Regulatory Authorities

  • Clinical Trial Administrator II

    Oct 2016 - Feb 2017

  • Clinical Trial Administrator I

    Dec 2015 - Sept 2016
• 

  Pra health sciences

  Mar 2017 - Sept 2020

  • Conducted Off Site Monitoring Visits with the Site Staff• Ensured consistency and accuracy of clinical trial data by performing off-site data review, including real time review • Performed Central Monitoring Risk Review and review of standard quality indicators • Provided regular site risk review information to team members and updates on trial management tools• Communicated with investigative sites representatives and updating applicable tracking systems• Close monitoring on vendor's laboratory results – contacting the lab representatives, follows up on delayed/cancelled samples• Performed support with subject eligibility review Show less • Conducted Off Site Monitoring Visits with the Site Staff• Ensured consistency and accuracy of clinical trial data by performing off-site data review, including real time review • Performed Central Monitoring Risk Review and review of standard quality indicators • Provided regular site risk review information to team members and updates on trial management tools• Communicated with investigative sites representatives and updating applicable tracking systems• Close monitoring on vendor's laboratory results – contacting the lab representatives, follows up on delayed/cancelled samples• Performed support with subject eligibility review Show less

  • Central Monitoring Associate

    Sept 2019 - Sept 2020

  • Central Monitoring Associate

    Apr 2019 - Aug 2019

  • In-House CRA

    Mar 2017 - Mar 2019
• 

  Icon strategic solutions

  Oct 2020 - now

  • Leading cross-functional teams, including Clinical Trial Administrators, Clinical Research Associates, Study Start up Manager, and Clinical Supply Specialists to ensure effective collaboration and communication. • Resourcing, line management, training, functional delivery and input on discussions around quality and operational delivery measurements within the Clinical Operations group.• Conducting regular discussions with direct reports and lead team meetings at regional and manager team level.• Preparing and presenting reports on direct reports progress, metrics, and outcomes to stakeholders, including senior management and sponsors. • Providing training and support to team members and new hires, fostering a culture of continuous learning. • Driving overall delivery at site and regional level, through the operational team to drive execution of service, client satisfaction, quality and efficiencies Show less • Managed and executing global Analytical Risk-Based Monitoring (ARBM) activities for allocated clinical trials in accordance with standard operating procedures, all relevant laws, regulations, guidelines, policies and good clinical practices• ARBM study related tasks and processes such as finding risks, creating risk management and monitoring plans. Executing these plans and centrally monitoring the ongoing studies in collaboration with study teams• Participated in Central Monitoring Working Group (CMWG) that works and decides on study related risks/trends and relevant actions/processes• Identified potential issues and findings requiring further review and follow up as part of CMM work and ensures appropriate actions are taken by the global/local teams members to investigate, resolve and document potential risks identified via data review, including ensuring adequate documentation of resolution• Followed up the resolution of issues found• Contributed to the ongoing development of the ARBM model of clinical trial management and related processes Show less

  • Manager of Clinical Operations

    Jul 2023 - now

  • Central Monitoring Manager

    Oct 2020 - Oct 2023