Pleasanton, CA (applicants must already be local to the area)
Estimated Pay Rate: $58-$75 /hr (w2 only)
1-3 year contract
JOB SUMMARY: this role is a hybrid type position between the typical Clinical Operations Study Manager and a Project Manager role. This will be Involving multiple non-registrational Medical Affairs studies. This person will have a Scientific background with a proven track record of Project Manager skills. You will Review CRAs, write protocols, training materials etc.
- Hold a Minimum of a Bachelor degree in scientific discipline.
- Strongly prefer those who have worked at Sponsor companies rather than at CROs
- Recent years of experience in diagnostics, biotechnology and/or pharmaceutical clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation, and delivery of clinical programs.
- HIGH Understanding of US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.).
- Should have up-to-date knowledge of applicable standards and regulations for clinical trials and laboratory conduct (CFR, ICH-GCP, Federal guidelines, GMP, GLP, ISO, etc.)
TRAVEL REQUIREMENTS: MAY eventually require roughly 20% of time travel domestic and/or international.