In this role, you will have a wide range of responsibilities. You are a member of the Study Management team of the R&D department and responsible for the studies of in-vitro diagnostics as well as studies with international cooperation partners (WHO, FDA, etc.) according to ISO: 13485.2016. Your key tasks are planning, coordinating and supporting of national and international clinical studies. 

To be successful in this role, you will need to be experienced with molecular genetic technologies:  DNA/RNA extraction methods, different amplification technologies etc. (in theory and practice). Furthermore, you should be a communicative person with a wide range of technical knowledge that you are able to negotiate with study partners in a friendly and convincing way. In addition, there must be a willingness to travel within and outside of Europe (up to 30 % travel activity).

• Member of Study Management team of the R&D department at Bruker-Hain
• Supervision of national and international validation studies of in-vitro diagnostics as well as studies with international cooperation partners (WHO, FDA, etc.)
• Finding suitable international and national study partners
• Agreement of the study conditions with study partners
• Creation of study plans according to ISO 1348
• 5: 2016 and IVD-R
• Sample size planning and statistical analysis
• Theoretical and practical training courses for the study partner on site if required
• Monitoring of studies on site if necessary
• Clarification of the financial expenses for studies in consultation with the R&D management and the management
• Evaluation of study results
• Creation of publications based on study results
• Preparation of publications of study results
• Preparation of documents for specialist articles
• Creation and holding of specialist lectures

• Completed degree in biochemistry, biology or biotechnology
• Experienced with DNA/RNA extraction methods and different amplification technologies (Realtime PCR etc.)
• Experience with sample size planning and statistical analysis
• Fluent in written and spoken English (mandatory)
• Communicative
• Motivated