Małgorzata Kowalska
Warsaw, Poland
Summary
Clinical Trial Professional with 3 years of experience, including 2 years as a Project Coordinator in early-phase oncology and hematology studies. Skilled in supporting clinical trials, managing trial documentation, tracking project progress, and ensuring compliance with regulatory standards. Experienced in vendor management, risk tracking, and coordinating with cross-functional teams to ensure smooth trial execution. Organized, detail-oriented, and passionate about contributing to the success of clinical research.
Professional project specialist equipped to excel in coordinating and managing project activities. Brings strong focus on team collaboration and delivering results. Skilled in scheduling, budget management, and stakeholder communication. Reliable and adaptable, ready to meet changing project needs and ensure successful outcomes.
Overview
3
3
years of professional experience
Work History
Project Coordinator I
Fortrea (Formerly Labcorp
01.2023 - Current
- Serve as the right hand to the Project Manager, ensuring seamless project execution by tracking and maintaining key project performance indicators (KPIs) aligned with client-specific metrics.
- Act as the Project Vendor Manager, coordinating vendor services, managing contracts, conducting budget reconciliations, and approving invoices.
- Support the management of budgets, timelines, and quality guidelines to ensure projects are delivered on time and to the highest standards.
- Facilitate the design, implementation, tracking, and revision of project plans, ensuring alignment with study protocols and objectives.
- Conduct Out-of-Scope (OOS) hours reviews to manage project scope effectively.
- Oversee electronic Trial Master File (eTMF) operations, including preparing quality control (QC) reviews, identifying and resolving documentation gaps, and driving improvements in completeness and compliance.
- Track and document key actions, decisions, and risks, ensuring comprehensive oversight and proactive mitigation strategies.
- Handle access management at the study level to ensure secure and proper access for team members.
- Prepare and distribute study newsletters to update sites on progress and key information.
- Create and maintain study trackers
- Track and document actions, decisions, and risks to keep the project organized and resolve issues quickly.
- Prepare slides for meetings and take clear, detailed meeting minutes to track progress and follow up on tasks.
- Responsible for oversight and reconciliation of Investigator Grant Payments
Clinical Trial Assistnat
ICON plc
01.2022 - 12.2023
- Supported Project Managers (PMs) and Clinical Trial Managers (CTMs) in daily tasks to ensure smooth trial operations.
- Ran and analyzed query reports from multiple systems, identified discrepancies, and escalated issues to Clinical Research Associates (CRAs) and CTMs for resolution.
- Managed Trial Master File (TMF) documentation using Veeva Vault, ensuring accurate and timely filing in compliance with standards.
- Provided system access for study team members and site staff, maintaining proper user permissions across various platforms.
- Sent reminders and escalation emails to site teams, offering proactive support to CRAs and CTMs
Education
Postgraduatee - Conducting and Monitoring of Clinical Trials
Kozminsky University
Warsaw, Poland06.2023
Master of Science - Biology
University of Agriculture in Krakow
Cracow, Poland07.2021
Bachelor of Science - Biology
Jagiellonian University
Cracow, Poland09.2019
Skills
- Task prioritization
- Meeting facilitation
- Financial forecasting
- Contract management
- Project oversight
- Organizational skills
- Attention to detail
- Team collaboration
Languages
Polish
First Language
English
Advanced
C1
Data Consent
I agree to the processing of personal data provided in this document for realising the recruitment process pursuant to the Personal Data Protection Act of 10 May 2018 (Journal of Laws 2018, item 1000) and in agreement with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation).
Timeline
Project Coordinator I
Fortrea (Formerly Labcorp
01.2023 - Current
Clinical Trial Assistnat
ICON plc
01.2022 - 12.2023
Postgraduatee - Conducting and Monitoring of Clinical Trials
Kozminsky University
Master of Science - Biology
University of Agriculture in Krakow
Bachelor of Science - Biology
Jagiellonian University
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