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Evidence generation to support growth of the Company´s portfolio:
- Ensure good clinical practice and adherence to applicable regulations and standards related to clinical studies of medical device
- Ensure continuous updating/improvements of the documentation and processes related to clinical studies
o Design, documentation, monitoring, close out of clinical studies
o Presentation of study data in reports and publications
o Judgment of statistical evaluations
o CRO evaluation and cooperation
o Contacts with current or potential new clinical study sites
o Project Management for Clinical projects
- Ensure adherence to applicable regulations and standards/common specifications related to clinical evaluations and other clinical regulatory documents
o Clinical evaluations
o Post market surveillance & reports
o Clinical adverse events and complaints handling
o Update and improvements of clinical Management- and post market surveillance SOPs
o Update and improvements of the complaint SOP
If you are interested and have relevant experience please contact Niklas Claesson