Clinical Project Manager (f/m)

      Personal-Basis Management GmbH

      Wien - vor 1 Monat

      Our client is a young, ambitious biotechnology company in Vienna that primarily specializes on the development of innovative products against various infectious diseases and is driven by the clear objective to advance promising products from preclinical to late-stage clinical development phases, in order to establish national and international collaborations.

      Clinical Project Manager (f/m)

      Your Responsibilites

      • Oversee the performance of CROs and of third party vendors, including co-monitoring to guarantee compliance with study protocol
      • Ensure study timelines are met, study progress is reported and tracked to keep the study status, goals and budget maintained
      • Prepare clinical protocols, amendments, informed consent forms, study guides, case report forms and any other clinical research related documents
      • Perform the clinical data review of data listings and summary tables, including query generation
      • Review key study quality metrics (e.g. eligibility, primary endpoint data, etc.) and determine appropriate action
      • Ensure studies are carried out according to the study protocol, SOPs and ICH/GCP regulations as well as study-specific manuals and procedures
      • Investigate queries, monitor discrepancies and escalate to Head of Clinical & Pre-Clinical Development to resolve issues pertaining to the timely completion of the drug development process
      • Monitor the performance of the investigational sites for clinical studies; prepare accurate and timely reports from all site interaction visits
      • Participate in CROs / Vendors site qualification and site monitoring activities; nationally and internationally (US)

      Our Expectations

      • Broad scientific background with an advanced university degree is highly appreciated (e.g. molecular-biology, immunology, virology)
      • Prior experience within the pharmaceutical industry or a biotechnology company focusing on international clinical project management.
      • Proven expertise in managing international clinical studies and coordinating national and international CROs / Vendors (US) - therefore readiness to travelling is requested
      • Strong knowledge of GCP and ICH guidelines and clinical development processes
      • Ability to interpret data in a concise and clear manner
      • Proven document management, organizational and administrative skills
      • Self-starter who lives drive and initiative with a performance-oriented mentality
      • Great ability to work hands-on in a small team
      • Strong verbal and written communication, presentation and social skills
      • MS-Office skills (Excel, Word, Power Point, Outlook, etc.)
      • Fluency in English and German

      Would you like to be part of a strong team with dedicated and passionate scientists? And do you look for personal development opportunities in a rapidly expanding company with an excellent working atmosphere?

      For this position our client offers a yearly gross salary of EUR 50.000,-. Overpayment is possible depending on experience and qualification.

      Do you feel addressed? Please send your application to
      Dr. Martina Pfister-Kraxner, e-mail: Tel: +43 664 2323 875

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