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Clinical Study Manager (m/f) Mainz Germany,  

Biontech (company)


Posted on : 10 April 2017

Project Description

Description:
  •  Everyone achieves greatness at our company.
  •  As one of the most rapidly growing biotechnology companies in Europe, we re working on revolutionary approaches in the fight against cancer and other diseases. 
  • Over 500 dedicated, passionate pioneers achieve sensational success and promising breakthroughs time and again by forging new paths  and ensure people all around the world have hope for the future. You too can become a pioneer!  Here, you ll achieve greatness. 
  • As a part of our clinical research team, you will soon take the next critical step with us. 
  • Together with your colleagues, you will supervise clinical studies and help our company become a worldwide forerunner for modern immunotherapies against cancer. 



Your duties in detail:  
  • You will be responsible for upholding project timelines, quality standards and study objectives. 
  • This includes preparing and clearing study documents with CROs and overseeing the selection of contract partners. 
  • You will compile documents for the authorization of clinical studies, for ethics commissions and for federal authorities. 
  • You will also prepare and conduct training sessions relevant to the studies as well as team and investigator meetings. 
  • Additionally, you will prepare study information according to regulatory requirements.   



What you have to offer.  
  • Successfully completed science degree or medical vocational training 
  • Already Experience as a Clinical Study Manager, CRA/Clinical Monitor (m/f) or in a similar function 
  • Very good knowledge of relevant laws and regulations, such as the ICH GCP guideline 
  • You are proactive, autonomous and have excellent communication and organizational skills 
  • Professional handling of MS Office programs   

Locations

Mainz

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