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Job #03051

About our client Our client is a biopharmaceutical company that develops and commercializes therapeutic medicines for the treatment of serious medical conditions. The company is focused on the professional development of its employees. This is a great opportunity for the right candidate! Position Location Senior Clinical Project Manager Waunakee, Wisconsin Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead the administration and project management of multiple phase clinical trials 2) Handle research and protocol development 3) Oversee in-house and on-site monitoring of trials (as necessary) 4) Ensure adherence to GCPs and other company regulations 5) Oversee partnering companies on associated projects 6) Handle development of protocol/amendment 7) Manage review of all applicable literature (SBAs, FDA guidance and other publications) 8) Handle reviewing of CRF design, modification/creation of ICF, investigator brochures, study-related forms/reports and source documents in collaboration with the CRO, Data Management Group and Biostatistician 9) Maintain financial records 10) Handle all project-related budget/finance issues Requirements 1) MS in Life Sciences or a related field 2) 10+ years of clinical research or related experience 3) 5+ years of experience in clinical project management 4) Experience in a key CRO/pharmaceutical operational function (e.g., data management, clinical operations, laboratory and pre-clinical) 5) Knowledge of clinical study guidelines (FDA, ICH and GCP) 6) In-depth understanding of the clinical trials process 7) Excellent communication skills (written and oral) 8) Detail-oriented