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Asta Maziliauskaite

Asta Maziliauskaite

Engineer Biologist

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location of Asta MaziliauskaiteLithuania

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  • Timeline

  • About me

    Regulatory Affairs and Start-Up Specialist, CRA (unblinded CRA, remote CRA), Contract Negotiator (delivery of mediator services between site and Sponsor)

  • Education

    • Vilniaus Universitetas

      1997 - 2002
      Bachelor of Science (B.Sc.) molecular biology

    • Vilniaus Universitetas

      2005 - 2007
      Master Genetics

      Activities and Societies: None Engineer biologist 5 years at molecular biology laboratory (National Veterinary Laboratory) in the area of genetically modified organisms detection, identification and quantification in food and feed, assistance in molecular biology laboratory set-up, method validation, proficiency testing, laboratory accreditation for EU standards, PHARE projects. Training stage and junior laboratory staff.

  • Experience

    • National Food and Veterinary Risk Assesment Institute

      Jan 2003 - Mar 2007
      Engineer Biologist

      Engineer biologist in the area of genetically modified organisms detection, identification and quantification in food and feed, assistance in molecular biology laboratory set-up, method validation, proficiency testing, laboratory accreditation for EU standards, PHARE projects. Training stage and junior laboratory staff.

    • MSD

      Mar 2007 - Jun 2008
      Clinical Research Associate

      Clinical Research Associate in Lithuanian and Latvian sites, phase III: endocrinology, cardiology, phase II: pulmonology. SIVs, Monitoring, Close-out, assistance to audit. CTMS, Phase Forward InForm, IVRS.

    • Chiltern International

      Aug 2008 - Feb 2010
      Clinical Research Professional (CRA&CSUS)

      Initiated and monitored clinical trials in Italy, phase III two studies in neurology, phase IV: ophthalmology; contract negotiation, involved in study submission to EC and RA; PRISMA, Phase Forward InForm eCRF, IVRS/IWRS.

    • KCR

      Apr 2010 - Jan 2014
      Senior Clinical Research Associate

      Initiated and monitored phase III: two oncology studies, phase II: urology; performed feasibility, submission to EC and RA, paper CRFs and eCRF Viedoc, contract negotiation, payment coordination, responsible for CRO Representative Office Administration, involved in HR Management.

    • JSC Sosdiagnostics

      Sept 2014 - Dec 2016
      Project Manager

      Project management. Establishment of new laboratory department, facility rental and reconstruction coordination, negotiation with vendors, equipment selection and purchase, method implementation. Cooperation with architects, Regulatory institutions. Quality Assurance assistance: preparation for Lab Accreditation, SOP writing.

    • PRA Health Sciences

      Feb 2017 - Sept 2020
      CRA II

      CRA for clinical trails in Neurology area, MS, one pediatric study and one adult study, both phase III studies. Start-up, monitoring, close-out, submission to EC, contracts. This is my experience of last 3 years. Currently looking for new CRA opportunity, part time or full time. Using OC-RDC eCRF system, IMPACT CTMS system, ERT, IVRS, and other related systems.

    • UAB ThermoFisher

      Jan 2021 - Jun 2021
      Senior Quality Control Specialist

      Laboratory testing for medicinal product manufacturing process control and final product quality control for Covid -19 vaccines parts

    • COMAC MEDICAL Ltd

      Sept 2021 - Mar 2024
      Regulatory Affairs Specialist 70% and CRA 30 %

  • Licenses & Certifications

    • InForm Phase Forward eCRF Technical Trainer

      CHILTERN INTERNATIONAL GROUP LIMITED
      Jun 2009