- Develop and maintain the clinical trial standards according to industry standards (CDISC, LOINC)
- Evaluate business requests for standard variables and develop standard variable proposals taking the variable context and all sources which describe the variable context into consideration
- Implement new standard variables in the DIA Metadata Repository taking the rules of the metadata model into account
- Present the standard variable proposal to the data standardization approval board and support this team in executing the review and approval
- Ensure that the interface to the clinical study teams is in place and that the study team members are instructed in applying the clinical data standards
- Develop training concepts and train the members who liaise with the study teams
- Contribute and develop of industry standards at the interface to Standard Development Organizations (like CDISC)
- Expert in Medical Informatics, Data Science, Computer Science, a related scientific field or equivalent working experience
- In-depth knowledge of clinical data standards
- Solid understanding of clinical trial processes including Protocol Design, Clinical Data Management, Statistical Programming, Biostatistics and Electronic Submission as well as profound experience in a clinical working environment
- Enjoy networking in international matrix organizations
- Excellent communication skills in English
- International pharmaceutical company
Reference number
433417/1
Contact
Phone:
+ 49 621 1788-4297
E-Mail:
positionen@hays.de
