Three 3 years of experience working for a clinical trial sponsor. Must have experience in the following US and international clinical trials; sitebased and central Institutional Review Board IRB management; clinical project management ensuring and improving Good Clinical Practice and enforcing clinical trial regulations in medical device and pharmaceuticals; managing study initiation, continuing review, changes in research and closure with IRBs; developing informed consent and supporting material; developing and executing processes for safety information; directing and training on Clinical Standard Operating Procedures and Clinical Operating Procedures; implementing electronic trial master file eTMF systems; inspection readiness and audit SME experience; developing standard operating procedures SOPs and work instructions WIs for Clinical Study Execution; and direct people management. The position is based in San Mateo, CA; however, telecommuting from a home office may also be allowed.
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