Internship in the field of Data Management
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:
1. Carrying out clinical system validations including documentation
2. Creation and maintenance of automated data downloads from clinical databases for data analysis purposes
3. Administration of clinical databases
4. Mapping of data into existing systems
5. Creation and automation of ad-hoc study reports for clinical project management
6. Support of documentation in connection with the implementation as well as validation and maintenance of various systems in Medical Affairs
7. Creation and maintenance of reports for the Medical Affairs department Vigilance
Your profile:
8. Bachelor or Information Technology, Computer Science, Database Management, or comparable degree
9. IT Systems Management experience
10. Experience with computer system validation and interface programming for databases
11. GCP knowledge, good knowledge of 21CFRPart11 compliance and sound ISO 14155 knowledge
12. Knowledge of regulatory requirements (MDD/MDR) is an advantage
13. Certified SAS programmer is an advantage
14. Knowledge and experience with R, GIT-like tools, ticket systems and Qlik desirable