Aneliya Knauthe

Angestellt, Manager Clinical Trials, BioNTech SE
Mainz, Deutschland

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

  • Bis heute 3 Jahre und 5 Monate, seit März 2022

    Manager Clinical Trials

    BioNTech SE
  • 10 Monate, Mai 2021 - Feb. 2022

    Specialist Clinical Trials

    BioNTech SE
  • 6 Monate, Juli 2020 - Dez. 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 Jahre und 5 Monate, Feb. 2015 - Juni 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 Monate, Juli 2013 - Dez. 2013

    Research assistant

    University Hospital Jena

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

  • 5 Monate, Mai 2012 - Sep. 2012

    Research assistant

    Hans-Knöll-Institut, Jena

    Analyzed samples on gene level

  • 4 Monate, Okt. 2009 - Jan. 2010

    Research assistant

    "Agrobioinstitut"; Sofia, Bulgarien

    Conducted functional genetics experiments

  • 4 Monate, März 2009 - Juni 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 Monate, Juli 2008 - Dez. 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 Monate, Juli 2007 - März 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 Jahre und 8 Monate, Okt. 2011 - Mai 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 Jahre und 11 Monate, Okt. 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

  • Deutsch

    Fließend

  • Englisch

    Fließend

  • Bulgarisch

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