*Clinical research experience in Pharmaceutical, Biotechnology, Medical Device and CRO
*Gap analyses of Site, Sponsor and CRO and quality management systems for clinical research
*Global quality requirements and global audits experience
*GCP/GLP audits including IVRS, EDC providers, CROs, central IRBs, central laboratories, Phase I units, sponsor system-process audits, clinical investigator sites and business partners.
*Clinical Development/Operations quality compliance lead (risk evaluation, process improvement and procedure development in clinical trials conduct
*Clinical document audits, e.g. CSRs, TMF, Annual Reports, etc
*Vendor Management, CAPA and Risk-Evaluation process developm...
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