Bruker Corporation

Study Support Expert (m/f/n)

Arbeitsort DE-BW-Nehren
Datum der Veröffentlichung 2 months ago(1/15/2021 8:09 AM)
Antrags-Nr.:
2020-9639
Anzahl offener Funktionen
1
Positionstyp
Regular Full-Time

Überblick

 

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).

Aufgaben/Verantwortlichkeiten

  • 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

Qualifikationen

  • 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

Optionen

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