Clinical Project Manager

Salary/Rate:Flexible, depending on experience
Job type:Perm
Town/City:Munich
Country:Germany
Business Sectors:Regulatory Affairs, Clinical
Job ref:24906
Post Date:31. 01. 2024
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About the Role

Clinical Project Manager
We have a unique opportunity for a Clinical Project Manager to work with Class III high risk implantable devices with an innovative business, manufacturing revolutionary devices to treat heart valve diseases.
You would be part of an incredibly talented, forward-thinking team.


Responsibilities:
  • Oversee clinical project management throughout the entire study lifecycle, including startup, execution, and closure
  • Assist in the development and composition of clinical study documentation as well as support the submission of study-specific documents to regulatory authorities
  • Ensure alignment of the study project with the clinical study protocol and relevant regulations
  • Document management including managing the filing, collation, collection, administration and tracking of essential documents
  • Supervise study progress and data collection, with a focus on adverse event reporting
  • Communicate with study sites to ensure protocol compliance
  • Conduct co-monitoring visits and other sponsor-triggered visits at clinical sites
  • Archive and administer scientific and medical literature

Your Profile:
  • Life science degree or fully-fledged study nurse
  • 2+ years experience as clinical project manager, preferably in medical devices
  • In-depth knowledge of ISO-14155, Good Clinical Practice, and national regulations such as MPG, MDR, and associated guidelines
  • Familiarity with electronic data capture
  • Excellent communication and organizational skills
  • Diligent, well-organized, and team-oriented performance
  • Proficient in Microsoft Office

Please apply with your CV or contact May-Lynn Capocciama-Knecht for further details on this opportunity and additional vacancies in Regulatory Affairs, Quality Management, R&D and Project Management.

may-lynn.ck@adaptivelifescience.com
+49 30 1663 7750

#LI-MC2