|DOCS Global, Inc.|
US-MA, Sr. CRA AS-004537-MZ
DOGS Global is looking for a Sr. CRA or Project Manager with previous monitoring experience!
· IVD (In-Vitro Diagnostic) experience is an absolute requirement.
· Current monitoring experience
· Responsible for clinical trials oversight in North America (US and Canada) for in-vitro diagnostics to support 510(k) submissions to FDA or registration with Health Canada
· Support global R&D and clinical research teams.
· Responsible for all activities involved in clinical trials establishment and execution
· Collaboration with clinical and regulatory teams providing submission to FDA and other agencies.
· Hands on clinical monitoring needed
· Must have experience in clinical trials resulting in FDA clearance of IVD products
· Must be experienced in looking at output reports that are run at the laboratories and clinical sites
· 5-7 years involved in pharmaceutical or Biotech industry
· PT CRA needed – 20 Hours a week through end of August with extension possibly FT based on performance.
· Need to start as soon as possible.
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