Duration: 6+ months
Start Date: ASAP
Job Description: Our client is currently looking to bring on a clinical affairs lead to help out with multiple critical projects all within the diagnostic field. They are about to finish up a study for a 510k and will need this resource to help with the study close-out as well as writing their clinical study report. The candidate will be working with biostats, data management, sample procurement and more between 3 sites to collect data, clean it up as well as the eTMF and write the CSR to the client’s templates. They will be managing this study and may need to go onsite to the different sites for study close out as well.
Once this project is done, the client immediately has a PMA study starting and will need this resource to be the clinical affairs lead and main contact for their core team. Here they will also be asked to visit multiple sites for study-start-up and then help manage the study and site interactions.
Skills:
Clinical Affairs
5+ years of diagnostic experience
Education: Bachelors of Science required
Clinical Affairs Manager- Diagnostics (233312) MN
