Required Skills: Manage the operational aspects of clinical trials Participate in protocol, CRF development, Clinical Study Report preparation, as appropriate Prepare metrics and updates for management, as assigned Proactively identify potential study issues/risks and recommends/implements solutions Participate in and facilitate CRO/vendor selection process for outsourced activities Manage CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files) May work with CRO to develop and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met Prepare and/or review/approve study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines) Manage clinical monitoring activities ensuring compliance with Good Clinical Practices (G
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