Clinical Evaluator and Project Manager - Med Tech Company - Life Science

Great opportunity to join a listed Med Tech Company with HQ in Sweden. We are looking for a Clinical Evaluator and Project Manager.

Role and Responsibilities

Evidence generation to support growth of the Company´s portfolio: 

Clinical studies 

- 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

Responsible for: 

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

Clinical management and compliance (Clinical Quality assurance)

-      Ensure adherence to applicable regulations and standards/common specifications related to clinical evaluations and other clinical regulatory documents

Responsible for:  

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