Our patients.
Our mission!

For the support of our clinical science department we are searching for a new fulltime team member 

Clinical Research Manager (m/w/d)

These are your tasks:

• Creation and maintenance of clinical regulatory documents (e. g. CER, PSUR)
• Planning, conduct and documentation of clinical evaluations according to current regulations
• Management of clinical investigations according to MDR, Declaration of Helsinki and ISO1455
• Set-Up of pre-clinical and clinical strategies in collaboration with various departments
• Active contribution to Berlin Heart’s Quality and Risk Management
  
• Collaboration with external service providers
  

You have the following qualifications:

• University degree in Medicine, Natural Science or Bioengineering with at least 5 years of professional experience in regulatory support and clinical investigations for Class III or active medical devices, preferably in cardiovascular area
  
• Profound knowledge and experience about the requirements imposed by medical device regulations
  
• Experience in data analysis, e.g for clinical study analysis, post-market surveillance and post-market clinical follow-up data
• Experience in performing systematic literature searches and in scientific writing
• Excellent English & German language skills, both written and oral

We offer you a modern workplace within a dynamic team. In addition to flexible working hours, this includes an attractive salary, occupational pensions, accident insurance and the security of an internationally operating company. Further more we offer health activities like fresh fruits, Yoga and fitness courses; discounted public transport; employee discount program and the possibility to work in the home office are further benefits. Look forward to a well integrated team and the benefit from the exchange of knowledge and experience among colleagues.

Berlin Heart GmbH develops, produces and markets innovative systems for mechanical cardiac support. With our products EXCOR® Adult and EXCOR® Pediatric we cover the complete spectrum of medical indications regarding cardiac support systems, as well as all age groups from newborns to adults. This makes the internationally active Berlin Heart GmbH among the market leaders in Germany and Europe.