Nickie’s experience includes the following: industry experience at contract research organizations (CRO) and biotech. Broad project management across matrix teams encompassing clinical development, alliance management, and business development. Study-level oversight and accountability for multiple functional departments to include project management, clinical operations, data management, pharmacovigilance, quality assurance, start-up and regulatory. Project and line management experience and strong organization skills. CRO business development activities including, client development, alliance relationship management, bid defense meetings, and project costing. Global clinical trial management experience including North America, Europe, Asia Pacific. In depth understanding of the drug development process, clinical trials conduct, GCP, ICH, FDA CFR and international regulations. Experience in Phase I – IV clinical trials, including multi-phase protocol design. Experience evaluating and performing due diligence of potential candidates. Experience in all steps of site start-up.
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