Aneliya Knauthe

Angestellt, Manager Clinical Trials, BioNTech SE
Mainz, Germany

Fähigkeiten und Kenntnisse

Clinical Research
Clinical Monitoring
ICH-GCP
Good Manufacturing Practice
Oganisational skills
Teamwork
Project Management
Six Sigma
oversight
Research and Development
Quality Management
International experience
attention to detail
Responsible
Communication skills
Flexibility

Werdegang

Berufserfahrung von Aneliya Knauthe

  • Current 4 years and 3 months, since Mar 2022

    Manager Clinical Trials

    BioNTech SE
  • 10 months, May 2021 - Feb 2022

    Specialist Clinical Trials

    BioNTech SE
  • 6 months, Jul 2020 - Dec 2020

    Clinical Trial Manager

    R-Biopharm AG

    Study-design, planning, submitting and conducting clinical performance studies to verify and validate in-vitro diagnostic tools (accroding to IVDR, MPDG, ISO 9001:2015 and ISO 20916:2019).

  • 5 years and 5 months, Feb 2015 - Jun 2020

    (Senior) Clinical Research Associate

    Premier Research Germany Ltd.

    • Phase I-III trials in Germany, Austria and Bulgaria • Visits: Site Selection, Site Initiation, Interim Monitoring, Remote, Motivational, Close-Out • site training, SDV, query resolution, drug accountability, site files, TMF, CTMS • site feasibility, start up activities, submissions, contract negotiations • translator at FDA inspection Indications: Oncology, Haematology, Gynaecology, Endocrinology, Immunology, Nephrology, Autoimmune Diseases, Paediatrics and Rare Diseases

  • 6 months, Jul 2013 - Dec 2013

    Research assistant

    University Hospital Jena

    Investigated cell cultures and samples on gene, RNA and protein level Processed large amounts of data

  • 5 months, May 2012 - Sep 2012

    Research assistant

    Hans-Knöll-Institut, Jena

    Analyzed samples on gene level

  • 4 months, Oct 2009 - Jan 2010

    Research assistant

    "Agrobioinstitut"; Sofia, Bulgarien

    Conducted functional genetics experiments

  • 4 months, Mar 2009 - Jun 2009

    Office Assistant

    “BioMed future” Ltd., Sofia, Bulgarien

    Traded with medical and laboratory equipment and products Customer service demeanour and data management Documented invoices, contracts and customers data base Prepared the annual business fair Translated technical descriptions

  • 6 months, Jul 2008 - Dec 2008

    Office Assistant

    “Dexion” Ltd.; Sofia, Bulgarien

    Documented invoices, contracts and customers data base Customer service demeanour and data management Prepared the annual business fair Translated invoices, purchase orders and technical descriptions

  • 9 months, Jul 2007 - Mar 2008

    Call Centre Agent

    "Market Test"; Sofia, Bulgarien

    Implement surveys and inquired about social and customer habits Maintained contact with former clients

Ausbildung von Aneliya Knauthe

  • 2 years and 8 months, Oct 2011 - May 2014

    Molecular Medicine

    Graduate School – Friedrich Schiller University, Jena, Germany

    Master thesis: “Natural compounds and their derivatives as modulators of Wnt/ß-catenin signaling” Highlights: Clinical Chemistry and Molecular Diagnostics, Medical Biometry, Molecular Pathology, Molecular Pharmacology, German, Russian

  • 3 years and 11 months, Oct 2007 - Aug 2011

    Biotechnology

    Sofia University „St. Kliment Ohridski”

    Experiment Design and Analysis, Foundations of Biotechnological Industries, Organic Chemistry, Biochemistry, Molecular Biology, Biophysics and Radiobiology, Microbiology, Virology

Sprachen

  • German

    C1 (Fließend)

  • English

    C1 (Fließend)

  • Bulgarisch

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