Experience

Novartis Poland

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Portfolio Team Lead

  • Sep 2023 - Present



PPD

• United States
• Research Services
• 700 & Above Employee

• Senior Training Specialist Global, Accelerated Enrollment Solutions (AES)

  • Jul 2021 - Sep 2023

  - Collaborating with project and program leads and management to prepare, organize, coordinate, document and provide expert development and delivery of various types of training- Help to support business outcomes and compliance by providing targeted training- Developing supporting materials, presentations, tools, micro learning and modules- Leading initiatives and projects to allow successful delivery- Performing needs analysis for clinical and non-clinical site staff members- Providing expertise, coaching and mentoring ot team members- Providing train-the-trainer sessions for management staff- Providing virtual and F2F training- New hires training- Cooperation with multi-departmental teams globally Show less

• Senior CRA

  • Jan 2021 - Jul 2021

• Clinical Research Associate II

  • Jun 2019 - Dec 2020



Janssen Polska

• Poland
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Site Manager / Clinical Research Associate

  • Mar 2017 - May 2019

  Main tasks and achievements: monitoring the course of all the research activities. Conducting feasibility and monitoring visits: pre-trial assessment (including early development trials), site initiation and start-up, site close-out. Site recommendations after evaluation visits. Communication with site teams, central and local teams and all the other clinical research participants. Training the site’s research staff. Verification of source data, quality control, site/trial status, data completeness in source and electronic documentation. Database close-out within the expected timelines. Completing administrative formalities concerning clinical study. Influence on the strategy regarding site patient recruitment process, collecting study documents, planning monitoring for a given study. Control of the Investigated Product (IP), correct transportation, storage and reporting about protocol discrepancies. Checking compliance of the investigational product, appropriate destruction of clinical supplies. Maintaining proper AE/SAE reporting. Experience with GMO study (including feasibility, pre-trial assessment, completing Ministry submissions). Show less

• Clinical Trial Administrator

  • Oct 2015 - Feb 2017

  Main tasks: preparing essential clinical trial documents. Communication with research participants, including the clinical research monitor. Organization and conducting meetings of the team involved in a given research project. Documenting information regarding the course of research. Completing legal and administrative formalities regarding registration of clinical research. In-depth analysis, registration and CT documentation archiving, work with the CTMS and mCTMS systems. Service and keeping track of changes in the TMF system. Overview and completing ISF, TMF documentation. Monitoring and reporting severe adverse events – serve as SAE Liaison for all projects. Visiting research sites. Show less



MSD

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Pharmacovigillance Safety Data Specialist

  • Jan 2015 - Oct 2015

  Main tasks: analysis and management of data concerning adverse events of company products being in the phase of clinical research (ranging from pre-clinical research through I – IV phase research) as well as available on market products. Data processing. Global database data entry. Ensuring highest-quality of reporting, analysis of research protocols. Communication with international teams and the specialized environment. Main tasks: analysis and management of data concerning adverse events of company products being in the phase of clinical research (ranging from pre-clinical research through I – IV phase research) as well as available on market products. Data processing. Global database data entry. Ensuring highest-quality of reporting, analysis of research protocols. Communication with international teams and the specialized environment.



Ursynowska Veterinary Clinic

• Warsaw, Poland

• Veterinary Surgeon, Internship

  • Nov 2013 - Sep 2014

  - On-hand experience at all veterinary medicine areas; - Performing examinations during daily appointments; - Monitoring of ongoing drug therapy protocols; - Management of veterinary services inquires. - On-hand experience at all veterinary medicine areas; - Performing examinations during daily appointments; - Monitoring of ongoing drug therapy protocols; - Management of veterinary services inquires.



Dr. Trevor’s Veterinary Hospital & Welfare Center

• Ta'Quali, Republic of Malta

• Internship

  • Jul 2013 - Aug 2013

  - Providing files for national administrative authorities; - Laboratory work: blood and other body fluids examination; - Assisting during surgeries and daily appointments; - Animals sheltering. - Providing files for national administrative authorities; - Laboratory work: blood and other body fluids examination; - Assisting during surgeries and daily appointments; - Animals sheltering.



Clinical Internship at the Annex Animal Hospital

• Toronto, Kanada

• Internship

  • Jul 2012 - Aug 2012

  - Detailed surgery data report draw ups; - Analysis of clinical examinations and laboratory findings; - Active participation during daily rounds; - Assisting during surgeries and daily appointments. - Detailed surgery data report draw ups; - Analysis of clinical examinations and laboratory findings; - Active participation during daily rounds; - Assisting during surgeries and daily appointments.



Externship at Small and Exotic Animals Clinic

• Prague, Czech Republic

• Internship

  • Oct 2011 - Nov 2011

  - Laboratory work: performing full blood work; - Assisting during daily appointments and surgeries. - Laboratory work: performing full blood work; - Assisting during daily appointments and surgeries.