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Clinical Study Manager (m/f) - Germany  

Biontech (company)


Posted on : 10 April 2017

Project 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