Clinical Project Manager (m/f)
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/f)
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
- 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
- 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
- At least 3-5 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
- IT Literacy required
- Team- and customer oriented, analytical and detail oriented, flexible and communicative personality with excellent soft skills
- Fluency in English language and basic German; any additional language is an advantage
Are you interested? Please apply online! We are looking forward to welcoming you.
Working hours: Vollzeit
Type of contract: Unbefristet
Job ID: 15322
Contact: Bianca Wisner
We do not accept applications from Headhunters.