Experience

Polish Association for Good Clinical Practice (GCPpl)
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Member

  • May 2023 - Present


ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Lead TMF Specialist

  • Feb 2023 - Present

  Study document management in accordance to sponsors requirements and GCP in Veeva Vault environment. Performing detailed administrative check, maintenance and quality review of the eTMF. Providing support to study team with document related queries. Study document management in accordance to sponsors requirements and GCP in Veeva Vault environment. Performing detailed administrative check, maintenance and quality review of the eTMF. Providing support to study team with document related queries.



ICON Strategic Solutions

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Central Statistical Surveillance Analyst

  • Jan 2021 - Feb 2023

  Using statistical methodology to determine patterns of data within a trial and identifying outliers which are potential issues in Analytical Risk-Based Monitoring. Analyzing the scope of data: Questionnaires, Lab, ECG & EDC. Providing additional layer of protection for subject safety and data quality for study teams. Leading the cross-functional team meetings.

• Risk Management Central Monitoring Specialist

  • Apr 2020 - Feb 2023

  Executing and managing the Analytical Risk-Based Monitoring and Central Monitoring process for assigned trials in conformance to relevant laws, regulations and guidelines. Performing the central clinical monitoring activities across different phases of the trial execution – trend analysis, identification of potential issues and findings in data requiring further review and follow-up. Leading the cross-functional team meetings. Ensuring appropriate actions are taken by the central/local teams members to investigate, resolve and document potential risks identified via data review. Ensuring adequate documentation of issues resolutions. Show less



KCR

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Patient Management Consultant

  • Nov 2019 - Mar 2020

  Maintain contact with patients participating in the clinical trial. Report results and updating database in accordance with the procedures. Perform duties of the employee representative. Maintain contact with patients participating in the clinical trial. Report results and updating database in accordance with the procedures. Perform duties of the employee representative.



University of Warsaw

• Poland
• Higher Education
• 700 & Above Employee

• Trainee

  • Jul 2017 - Sep 2017

  Centre of New Technologies Laboratory of Stem Cells, Tissue Development and Regeneration - practice as a part of the master thesis Applied techniques: DNA isolation from animal material, PCR, electrophoresis, running an adherent cells culture, preparation of buffers and culture media, isolation of skin and mouse cells, cutting material using cryostat, staining samples using antibodies Centre of New Technologies Laboratory of Stem Cells, Tissue Development and Regeneration - practice as a part of the master thesis Applied techniques: DNA isolation from animal material, PCR, electrophoresis, running an adherent cells culture, preparation of buffers and culture media, isolation of skin and mouse cells, cutting material using cryostat, staining samples using antibodies



Institute of Biochemistry and Biophysics PAS

• Trainee

  • Jun 2016 - Jun 2016

  Student professional practices at Department of Protein Biosynthesis Applied techniques: DNA isolation from plant material, PCR, electrophoresis, running a bacterial suspension culture Student professional practices at Department of Protein Biosynthesis Applied techniques: DNA isolation from plant material, PCR, electrophoresis, running a bacterial suspension culture