Clinical Development Manager (f/m/d)
AOP Orphan
Vienna
vor 6 Tg.

Professional Skills

  • Natural science / scientific background (HTL, FH, university)
  • Experienced in medical writing of clinical documents (clinical study protocols, clinical study reports, publications, clinical sections of dossiers and regulatory documents)
  • Experienced in clinical development, ideally in designing clinical studies, biostatistics, interpretation of clinical data
  • GCP knowledge
  • Strong communication and presentation skills in English
  • IT skills (Office 365, Adobe Acrobat, alternatively MS-Project)
  • Ready for an ambitious job?

  • You develop the design, synopsis, protocol, amendments and final reports for clinical studies
  • You support regulatory interactions addressing questions and responses
  • You prepare and contribute to scientific documents (e.g. safety annual reports, clinical trials and submission documents)
  • Like to take accountability?

  • You are involved in the identification of potential investigational sites and you support during trial conduct
  • You present clinical data internally and externally (incl. publications)
  • You maintain awareness of new developments within our core therapeutic areas building upon own expertise through attendance at congresses, seminars and meetings
  • Able to align?

  • You offer medical / scientific advice and training to AOP Health personnel as needed
  • You work closely with stakeholders including Department Heads, CSO and CMO
  • You participate in multidisciplinary project teams and you work with other functions in the assessment of new in-licensing opportunities
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