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Clinical Data Manager (m/w/d)

BIOTRONIK AG
Bülach, CH-ZH

6T

Clinical Data Manager (m/w/d)

Clinical Data Manager (m/w/d)

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

The Clinical Data Operations department is responsible for data management and statistical analysis of our international clinical trials.

Your tasks:

  • Carrying out clinical system validations including documentation
  • Creation and maintenance of automated data downloads from clinical databases for data analysis purposes 
  • Administration of clinical databases
  • Mapping of data into existing systems 
  • Creation and automation of ad-hoc study reports for clinical project management
  • Support of documentation in connection with the implementation as well as validation and maintenance of various systems in Medical Affairs
  • Creation and maintenance of reports for the Medical Affairs department e.g. Vigilance

Your profile:

  • M.Sc. Information Technology, Computer Science, Database Management, or comparable degree
  • IT Systems Management experience
  • Experience with computer system validation and interface programming for databases
  • GCP knowledge, good knowledge of 21CFRPart11 compliance and sound ISO 14155 knowledge
  • Knowledge of regulatory requirements (MDD/MDR) is an advantage
  • Certified SAS programmer is an advantage 
  • Knowledge and experience with R, GIT-like tools, ticket systems and Qlik desirable

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Bülach, Zürich | Working hours: Vollzeit  | Type of contract: Unbefristet 

Apply now under: www.biotronik.com/careers

Job ID: 37901  | Contact: Juliane Sasse 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.