Experience

Kozminski University

• Poland
• Higher Education
• 300 - 400 Employee

• Manager of Postgraduate Studies

  • Oct 2022 - Present

  Manager of postgraduate studies "Project management in clinical research"

• Lecturer

  • Oct 2021 - Present

  Contracted lecturer at postgraduate studies: Conducting and Monitoring of Clinical Trials

• Substantive Coordinator (Health Care Studies)

  • Jan 2021 - Oct 2021

• Assistant of the Studies Manager

  • Feb 2020 - Dec 2020



AIDIFY

• Poland
• E-Learning Providers
• 1 - 100 Employee

• Subject Matter Expert

  • May 2022 - Present

  Preparation of training materials on subjects related to Clinical Documentation / Trial Master File (TMF) and Good Clinical Practice (GCP). Preparation of training materials on subjects related to Clinical Documentation / Trial Master File (TMF) and Good Clinical Practice (GCP).



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager, Clinical Documentation

  • Oct 2021 - Present

  Responsibilities: - As the FSO Operations Lead, the main point of contact from the organization for Third Parties` (CROs`) Portfolio Leads on ensuring high quality of the documentation processes, procedures, and inspection readiness of outsourced studies. Collaborating on setup the mentioned processes, - Ensure a sustainable model is in place to build capability in the organization and drive excellence in the creation and delivery of a TMF that meets regulatory needs for every clinical trial conducted in GSK, - Support the embedding and implementation of eTMF and associated systems across Pharma R&D by working directly with Study Teams as they use the eTMF system to ensure inspection readiness throughout the study lifecycle, - A subject matter expert and member of a TMF Inspection Readiness Support team that guides study teams preparing for regulatory inspections, - Work with the business to improve our understanding of the challenges and associated solutions to ensure excellence in inspection readiness on a day-to-day basis, - Drive continuous improvement of specific processes/projects/ systems/programs/policies within clinical information management using change management methodology, - Build consensus through effective communications with relevant customer groups and project teams to ensure an integrated, comprehensive, enterprise solution continues to be implemented, - Work on KPIs standardization across fully outsourced studies with internal teams and Third Parties` (CROs`), - Taking part in process simplification activities, dedicated to TMF oversight and delivery from Third Parties` (CROs`), and clinical documentation-related processes, - Additionally, acting as a part of the Polish HUB Academy supporting mentoring program, providing webinars, and creating learning and supportive materials for Polish HUB members. Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Project Specialist

  • Mar 2020 - Sep 2021

  Responsibilities: - Set-up, maintain and/or close out project files and study information on the global level ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems, - Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure, - Maintains timely and effective communication among team members and site staff. Keep Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information, - Provide administrative support to Project Leads and functional leads, - Ensure all study documents are archived based on the appropriate guidelines and policy, - Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to a resolution on action able issues. Show less



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Specialist I (via Syneos Health)

  • Jan 2019 - Mar 2020

  Responsibilities:- Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/ Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems,- Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure,- Maintains timely and effective communication among team members and site staff. Keep Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information,- Provide administrative support to Project Leads and functional leads,- Ensure all study documents are archived based on the appropriate guidelines and policy,- Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to a resolution on action able issues,- Standard Operations Procedures (SOPs) review and preparations,- Investigator Study File and Templates Initiative Leader,- Provide needed trainings for all employees from the Region. Show less

• Senior Clinical Trial Administrator (via Syneos Health)

  • Jan 2019 - Feb 2020

  Responsibilities:- Performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions,- Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines, Creates and assists with maintenance of project files, handles project correspondence,- Participates in file audits,- Prepares and maintains site manuals, reference tools and other documents, - Maintains, updates, and inputs clinical tracking information into databases,- Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client,- Manages shared mailbox, processes site requests and routes correspondence appropriately,- Coordinates the ordering, packaging, shipping and tracking of site supplies and materials,- Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items,- Routinely anticipates, identifies and resolves potential issues and implements corrective actions, seeking guidance as needed to resolve more complex issues,- Maintains overall awareness in the field of clinical research, as well as assigned areas, by completing all necessary and assigned training,- May provide training or mentorship to more junior level Clinical Trial Administrators (CTA)/ Clinical Operations Specialists (COS). Show less

• Clinical Operations Specialist (via Syneos Health)

  • Aug 2018 - Dec 2018

• Clinical Trial Administrator

  • Nov 2017 - Dec 2018

  Responsibilities:- Provide (cross-functional) clerical and administrative support to project team(s),- Set-up and maintain project files and investigator files,- Contact study personnel at sites regarding (administrative) issues,- Generate, maintain and distribute study-specific reports (e.g. patient enrollment, regulatory documents, site visits),- Ship/mail supplies and documents to clients, investigator sites, and Ethics Committee,- Assist in assembling materials and binders for investigators' meetings,- Prepare ISFs (Investigator Study Files) and Pharmacy Binders for study sites,- Collection and preparation of essential/ required documents for submission to central Ethics Committee, and if necessary based on local requirements the Competent Authority,- Attendance in Co-Monitoring Visits at sites if needed,- Set up, maintain and review regulatory and administrative documents for the Trial Master File (eTMF). Show less



CROMSOURCE - A ClinChoice Company

• Italy
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Clinical Trial Administrator I

  • Oct 2015 - Oct 2017

  Responsibilities: - Cooperates with the project team with accurately updating and maintaining clinical tracking systems, - Preparation, handling, distribution, collection, filing and archiving of clinical documentation and reports according to the scope of work and the SOPs, - Prepares and requests the necessary local authorities approvals, - Collaborates with the project team in the preparation, handling, and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project), - Collaborates in managing the follow-ups of the monitor’s activities, - Preparation minutes from Project Team Meetings, - Manages the telephone monitoring of projects, - Involve into the international project for Clinical and Observational Trials with IMD and Medical Device. Show less



Central Forensic Laboratory of the Police in Warsaw, Biology Department

• Warszawa, woj. mazowieckie, Polska

• Intern

  • Aug 2014 - Sep 2014

  Responsibilities: - Isolation of DNA, - Evaluation of the amount of DNA in the sample using the method of Real - Time PCR, - Amplification of DNA fragments, - Conducting electrophoresis and evaluation of PCR products, - Preparation of bone material into the isolation of genetic material, - Assistance in inspection of materials collected from the crime scene, - Assistance in the implementation of project concerning research of Bloodstain Pattern Analysis (BPA), - Entering data into "Interpol" database. Show less



Orlen Medica Sp. z o.o.

• Płock Area, Poland

• Intern

  • Jul 2012 - Jul 2012

  Responsibilities: - Assistance in the hematological laboratory, - Assistance in the biochemical laboratory with immunochemistry, - Assistance in the analytics laboratory, - Assistance in the Registration and Point of Blood Aspirate. Responsibilities: - Assistance in the hematological laboratory, - Assistance in the biochemical laboratory with immunochemistry, - Assistance in the analytics laboratory, - Assistance in the Registration and Point of Blood Aspirate.