Experience

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  University of warsaw

  Jul 2015 - Jul 2015

  Volunteer

  Determining the species composition in undergrowth (hornbeam forests Tilio-Carpinetum in Białowieża, Poland) and estimating attendance using Braun-Blanquets method.

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  Uniwersytet warszawski

  Mar 2016 - Jun 2016

  Volunteer

  Obtaining cryosections of murine teratomas, basic histological stainings.

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  Maria skłodowska-curie memorial cancer centre and institute of oncology

  Jul 2016 - Jul 2016

  Intern

  Immunology: Investigating the influence of vitamin D analogues on HT29 cells preselected with 5-fluorouracil. Analysis of the expression level of selected genes in human leukocytes (RNA isolation, PCR)

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  Mossakowski medical research centre polish academy of sciences

  Aug 2016 - Aug 2016

  Intern

  Stem Cells Engineering: Obtaining and in vitro culturing of Wharton’s Jelly-derived human mesenchymal stem cells and culturing human induced pluripotent stem cells.

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  Medimmune

  Jul 2017 - Aug 2017

  Intern

  Respiratory, Inflammation & Autoimmunity: Investigating the influence of murine TSLP cytokine on murine splenocytes and murine bone marrow-derived dendritic cells. Detection and quantifying selected cytokines via ELISA assay.

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  Astrazeneca

  Mar 2018 - Feb 2020

  Studies supported: - Asthma; phase IIIb- Asthma; phase IV- Chronic Obstructive Pulmonary Disease; observational- Type 1 Diabetes Mellitus; post-authorization- ovarian cancer; phase IIIbMain responsibilities:- To work with eTMF – upload documents, pull the reports, monitor the metrics, conduct periodic Quality Checks;- To reconcile invoices of contracted vendors;- To draft study-specific plans such as TMF Plan, Sponsor Oversight Plan, Communication Plan- To support Evidence Delivery Associate Director in MHRA Inspection (Jun 2019)- To participate in Always Inspection Ready initiative;- To act as Subject Matter Expert for Sponsor Oversight Plan in primary and secondary data collection studies;- To act as Subject Matter Expert for ANGEL documentation submission;- To act as TMF Champion. Engaged in additional activities involving creating Hub-promoting presentations for occasions like EXPO 2019 in Warsaw Site, participating in Standarization and TMF Champions groups. I also participated in European Respiratory Society congress in Madrid, 2019 and in Perspektywy Women in Tech Summit in Warsaw, 2019.In 2019 I was leading my own internal 'MeetEOR' project across Evidence Associates, which aim was to become great source of knowledge for Medical Evidence people, especially for new employees. Guide was created in collaboration with about 20 people and was delivered within initially set up timelines. 'MeetEOR' is currently widely used across Medical Evidence Hub by different functions. Show less

  • Evidence Associate in Medical Evidence Hub BioPharmaceuticals Unit

    Jan 2019 - Feb 2020

  • Study Management & Operations Contractor

    Aug 2018 - Jan 2019

  • Communications Contractor

    Mar 2018 - Aug 2018
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  Covance

  Mar 2020 - Apr 2021

  Project coordinator

  Study supported:- Type 2 Diabetes Mellitus & Chronic Kidney Disease; phase IIMain responsibilities:- To manage the collaboration between LabCorp and eResearch Technology, Abbott, MediCapital Rent and Greens;- To reconcile invoices for all contracted vendors;- To manage eTMF (full responsibility);- To monitor time-billing activities.- To lead Inspection Readiness processes internally and externally;- To support start-up activities on regional level;- To oversee and mentoring senior associate, dealing with administrative matters;- To prepare, finalize and distribute meeting materials: agendas, slides, meeting minutes, ADI logs. Show less

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  Astrazeneca

  May 2021 - Apr 2023

  Global study manager in study management & operations oncology unit

  Studies supported:- Non-Small Cell Lung Cancer; phase III (3 studies, top priority in AstraZeneca Oncology portfolio)Main responsibilities:- To manage Central Laboratories and Imaging vendors (Labcorp, Invitae, Calyx, RTOG)- To manage and boost recruitment across the world;- To build up and set up processes for effective sample tracking, sample testing and site credentialing of SBRT procedures;- To oversee imaging in the study - procedures, query resolution.- To monitor and manage finances for contracted vendors: budgets and invoices;- To act as a point of contact and escalation for all laboratory-related matters in the study;- To track individually crucial samples in the study, watch the timelines and the procedures followed by the sites and laboratories;- To monitor and support sample transfers from sites to laboratories; - To train local teams from lab-related processes, sample flows and lab procedures;- To create, own and maintain lab-related documentation – Scope of Work for vendors, manuals for laboratories, logs for sites (such as HBS log);- To update study-specific documentation such as ICFs, Clinical Supplier Oversight Plan, Global Study Management Oversight Plan, TMF Plan, Vendor Communication Plan, Monitoring Plan etc.;- To report Quality Events, write/review CAPA letters, manage QEs until resolution;- To consult EC/RA country-specific lab-related submissions;- To coordinate PRF changes for ct.gov updates;- To support data cleaning in eCRFs;- To organize and lead KOM with vendors. Show less

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  Icon plc

  Apr 2023 - May 2024

  Senior clinical trial manager delegated as vendor manager ii to sanofi

  Studies supported:- Relapsing Multiple Sclerosis, phase III, 38 countries, 63 languages, 12 scales (CLS, COA, eCOA, Imaging)- Non-Relapsing Multiple Sclerosis, phase III, 25 countries, 37 languages, 12 scales (CLS, COA, eCOA, Imaging)- Asthma, phase II, 14 countries (CLS)- three Prurigo Nodularis, phases III, ~20 countries per study, ~19 lab tests per study (CLS)Main responsibilities:- COA management: establishing list of instruments, reviewing correctness of newly created scales, obtaining copyright holders details and approval to use, licensing for translational services & e-implementation - eCOA set-up: preparing RFP for vendors, reviewing proposals & contracts, establishing processes, assisting in development of e-versions of COAs, conducting UATs, managing shipments of devices- CLS set-up: preparing RFP for vendors, reviewing proposals & contracts, planning testing, shipment and monitoring activities- Imaging set-up: preparing RFP for vendors, reviewing proposals, establishing processes of data collection and reconciliationBeing a part of working group focused on establishing new, effective ways of new vendor managers' onboarding & mentoring (e.g. mentoring guide and newcomer's checklist). Show less

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  Astrazeneca

  Jun 2024 - now

  Global study manager in study management & operations haematology unit