Clinical Trial Manager/Sr. Clinical Trial Manager

The Clinical Trial Manager (CTM) is a key member of Clinical Operations and will closely partner with the Associate Director, Clinical Program Management. Assist Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation. Day-to-day contact with counterpart at CRO and/or trial site; daily review and identification of potential issues or problems with the sites and communicates/escalates to Clinical Program Manager. Under supervision may serve as the key operational contact for Akero studies aiding in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs. Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required. Review of trip reports generated by CRO CRAs. Maintains study timelines. Coordinates review of data listings and preparation of interim/final clinical study reports, including resolving data discrepancies.