Development oriented pharmacy graduate with experience in conducting of clinical trials from Sponsor perspective seeking a chance to gain an experience in clinical trials monitoring.

Experience

  • Global Study Associate

    at AstraZeneca Pharma Polska

    September 2018 - at Present

    Województwo Mazowieckie

    Working in phase 1, 2b and 3 studies during study start up, maintenance and close out periods Prepared CSR appendices ahead of a deadline Participated in on-site MHRA inspection Acting as a mentor for new in role GSAs GSA TMF Network Leader Set up Veeva Vault eTMF, CTMS, SharePoint for studies Conducting trainings on TMF Managing study eTMF, conducting and overseeing TMF periodic Quality Checks on study, country and site levels, creating and maintaining TMF Plan Responsible for sample disposal process Organized three-day event combined of Monitors’ Meeting, Investigator Meeting and Executive Committee Meeting Performing tasks related to Patient Engagement (Thank you Cards, Lay Language Summary) Managing CTMS on study level, oversaw CTMS compliance on local level Releasing Monitor’s Newsletter Maintaining contact lists and system users up to date by granting and revoking access Setting up teleconferences and presenting during the GST meeting

  • Contractor

    at AstraZeneca Pharma Polska

    August 2017 - September 2018

    Województwo Mazowieckie

    Worked with eTMF (uploading documents to Veeva, reports, dashboards), IxRS, TrialManager, ERT, Spotfire, IMPACT, RAVE systems Co- worked with GSAMs: o During CAPA procedure regarding to SAE Email Alert Failure o Tracking cases of temperature excursion of IP from beginning of the study to a current moment Communicated via email with LSL during CAPA procedure and acquired information Managed SAE distribution list and SAE/follow up SAE alerts report Granted access to all study team members Administrative support

Education

  • Conducting and monitoring of clinical trials

    at The Koźmiński University

    2019 - at Present (1 year) Województwo Mazowieckie

  • Pharmacy

    at Medical University of Warsaw

    2013 - 2018 (5 years) Województwo Mazowieckie

Languages

  • Polish Native

  • English Negotiation

  • Spanish Elementary

Followers (2)

Hives