About me

I have more than 15 years of experience in Clinical Trials. I started my career in 1998 in the most recognized and leading CRO company, working my way up through the company’s ranks from administrative roles, and reaching the level where I was responsible for the monitoring, coordination, and management of trials and clinical operations management across Poland.

I have more than 4 years of experience as a Clinical Research Associate based in Poland and working for international, multicenter clinical trials within different therapeutic areas including allergology, pulmonology in adults and children, endocrinology, cardiology and so on.

During this time I have

  • Performed site selection, initiation, monitoring duties, and close-out visits in accordance with contracted scope of work and Good Clinical Practice.
  • Provided monitoring visits and site management for a variety of protocols across a full range of therapeutic areas.
  • Administered protocol and related training to the assigned sites, and established regular lines of communication with sites to manage ongoing project milestones and issues, and so on.

Additionally I have over 4 years of experience as a Clinical Research Manager, managing the internal Clinical Operations team, consisting of CRAs and Sr CRAs, CTMs (Junior Trial Managers) and Clinical Trial Administrators. As a manager I have supervised groups of up to 45 people in total. From 2007, as Associate Director of Clinical Sites Monitoring and Operations, I was undertaking the full range of responsibilities associated with clinical operations management across Poland. As such I was the supervisory lead for Managers of Clinical Operations and their teams of monitors, administrators, and clinical research specialists.

During that time I gained considerable experience in liaising with internal and external audit and inspection authorities (FDA, MOCK, EMEA, and local RA inspections) and in leading the associated preparation, coordination, and CAPa processes.

I also have the additional experience of designing, preparing and implementing many internal and external initiatives, including: the recruitment process, Open Doors, Carrier Days, CRAs SCHOOL, Internship Program, Biosimilars Knowledge Campaign, Talent Management, Vendor Management (including contractors and freelancers), Training plans and management for managers and monitors, Headcount management and Performance management.

My background as a social psychologist gives me a thorough understanding of peoples’ behavior, their personalities, motivations, needs, and many others processes which ensures that I cooperate effectively with different individuals and the various stakeholders involved in a typical project, whilst earning their respect as a manager.

I use my first rate interpersonal skills and to build a team work mentality, generating a positive team spirit, and good strong long-term working relationships. Importantly, I am very open and adapt easily to change and new environments, treating these situations as a source of new opportunities and new challenges, and crucially I am able to convince other people to take the same approach.

This in turn leads to excellent results.
I am therefore extremely well placed to help you drive the process of Clinical Trial Operations and Management towards success.

Please visit the next folder which details my services.