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 :
Associate 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 Responsibilities Your Profile
Manage entire lifecycle of clinical trials
Define and author all essential clinical study documentation as required by ICH-GCP, ISO 14155, FDA, PMDA and local legal requirements;
including the study report
Coordination and support of internal and external interfaces within clinical studies and build up strong relationships with key opinion leaders
Being on top of the main literature and competitive environment in the field, reviewing study data, coordinating and assuring high data compliance
Write, support and review draft publications for peer reviewed journals
University degree or equivalent in scientific or medical field
1-3 years of experience within Clinical Project Management
Know-how of international medical device regulations; basic medical knowledge as well as good knowledge of ISO 14155 and / or ICH-GCP
Team- and customer oriented, analytical and detail oriented, flexible and communicative personality with excellent soft skills
Fluency in English and basic German; any additional language is an advantage
Are you interested? Please apply online! We are looking forward to welcoming you.