Excellent communicator with can-do attitude and strong desire to learn. Project Manager with line management responsibilities focused on quality. Currently fulfilling the role of an Oversight Portfolio Manager working on a governance level, responsible for several studies of one client and oversight and support a group of CTMs allocated for those projects. Client oriented and dedicated team player. Long-term goal is to have an independent and responsible position as a global project director. Experience in pharmaceutical marketing, medical affairs and clinical trials gained in pharma companies and CROs.Founder and member of Polish Pharmaceutical Students’ Association. Member and head of the training group at Polish Association for Good Clinical Practice (GCPpl). Pharmacist with strong interest in clinical pharmacy. Academic teacher delivering lectures related with clinical trials.

Certificates: Soft Skills Trainer Certificate, Prince2 Foundation Training Certificate, Barnett GCP Certificate. Laureate and winner of a 3rd place of the national competition “Leaders of Clinical Trials (2021)” in the category Project Manager. Scholar of Leslaw A. Paga Foundation in the program “Healthcare Leaders”.

Privately foodie and enthusiast of cooking, travelling and fantasy books.

Lucas is an accomplished clinical trial quality expert with nearly two decades of experience in Good Clinical Practice (GCP) across SMO and CRO environments. With a strong background in leadership and oversight, he has held senior responsibilities in Quality Assurance and Clinical Quality, ensuring that clinical trial activities meet high standards of regulatory compliance, patient safety and data integrity. quality management systems within the pharmaceutical industry. What gives me him unique perspective on this subject is his dual experience - having had the privilege of working both within the Polish Regulatory Authority and on the industry side, collaborating with organizations that plan and conduct clinical trials. This dual background allows him to understand the expectations of regulators while deeply appreciating the practical, day-to-day realities of trial operations.

His expertise includes an advanced understanding of global clinical trial regulations and practical experience overseeing, preparing for and hosting major regulatory inspections, including those conducted by the FDA, MHRA and BfArM. He has worked across multiple quality functions, including Quality Management System development, implementation and maintenance; audit and compliance activities; root cause analysis; and corrective and preventive action planning.

His specialist areas include building and maintaining robust Quality Management Systems, designing annual audit programmes, conducting vertical, horizontal, directed, routine and for-cause GCP audits, managing GCP vendor audits and oversight, and supporting inspection readiness. This breadth of experience enables him to provide practical, regulation-focused insight into clinical trial quality and compliance.

Monika Czerwiński is a seasoned clinical research executive with over 14 years of industry experience. She serves as Executive Director at HolsäClinical, part of the Gyncentrum Group, where she leads the strategic development and scaling of a nationwide network of clinical research sites.

She is the founder of Trial Leaders Academy, a platform dedicated to developing the next generation of clinical research leaders. She is also an active member of the GCPpl community, where she leads the Clinical Research Coordinators School, contributing to the advancement of professional standards across the industry.

Monika brings comprehensive expertise across the full clinical trial lifecycle, with a background spanning roles in study coordination, monitoring, and site management. She has successfully led initiatives across multiple therapeutic areas, including oncology, hematology, cardiology, gynecology, and dermatology.

She holds a degree in Biomedical Engineering from the University of Silesia and completed postgraduate studies in Project Management at the Warsaw School of Economics. Her core expertise lies in clinical trial feasibility and the effective execution of study start-up and site operations at scale.

Since 2020, she has played a pivotal role in shaping HolsäClinical’s growth and operational model, driving innovation in clinical research delivery in Poland. She combines deep operational insight with a forward-looking approach, with a particular focus on leveraging artificial intelligence in clinical trials.

A recognized speaker and thought leader, she actively contributes to industry dialogue, promoting higher standards of quality, efficiency, and innovation in clinical research.

She has been involved in the clinical research industry since 2015. She currently works for a global pharmaceutical company as a Manager in the Clinical Documentation team, where her main role is FSO Operations Lead.

She places high value on personal development and the quality of performed activities, which makes her a valued member of project teams. She has operational experience gained in global CROs and pharmaceutical companies. She has worked on both investigational and medical device projects in a variety of therapeutic areas.

From the very beginning of her work in clinical research, she has struggled with the complex nature of clinical trial documentation and TMF, which she continues to explore to this day.

In addition to her day job, she is actively involved in the academic community, initially as a coordinator and support to the manager of a post-graduate study in the clinical trial area. Currently, she is a lecturer at Conducting and Monitoring Clinical Trials and Associate Director in Third Party Processes & Operations.

This collaboration started after the previously completed postgraduate studies in Conducting and Monitoring Clinical Trials. Graduate of Nicolaus Copernicus University in Torun in the faculties of molecular biology and environmental protection.

Although she started her professional life at the Central Forensic Laboratory of the Police, she now finds herself perfectly at work in clinical project activities and now she is conducting other types of investigations.