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Clinical Project Manager (m/w)

BIOTRONIK AG

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Clinical Project Manager (m/w)

As one of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day

Please join us as

:
       Clinical Project Manager (m/w) 

The Medical Affairs Group is responsible for the design, conduction and evaluation of international first-in-men, regulatory submission and  post-marketing trials as well as investigator initiated trials.

Your ResponsibilitiesYour Profile

  • Conduct and oversight  (timely progress) of international clinical studies within agreed timelines and budget and maintaining regular contacts with investigators
  • Define and author all essential clinical study documentation as required by ICH-GCP, ISO 14155, FDA, PMDA and local legal requirements
  • Coordination and support of internal and external interfaces within clinical studies and build up strong relationships with key opinion leaders
  • Assure the handling and reporting of safety information in clinical studies according to regulatory requirements as well as readiness for internal and external audits
  • Being on top of the main literature and competitive environment in the field, reviewing study data, coordinating and assuring high data compliance
  • Preparation of clinical study reports for regulatory authorities as well as abstracts and presentations for congresses
  • Support and review draft publications for peer reviewed journals
  • University or bachelor`s degree in science; medical education is an advantage
  • 2 years of Clinical Project Management
  • Experience in international medical device regulations; basic medical knowledge as well as good knowledge of ISO 14155, CRF and relevant guidelines
  • Literate in Microsoft Office applications
  • Fluency in English and basic German; any additional language is an advantage
  • Team- and customer oriented, analytical and detail oriented, flexible and communicative personality with excellent soft skills

Are you interested? Please apply online! We are looking forward to welcoming you.

   

Location:  

Working hours: Vollzeit  

Type of contract: Unbefristet

Job ID: 4323

Contact: Juliane Liebsch               

                              

We do not accept applications from Headhunters.