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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