• Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants that are involved in a clinical trial • Lead cross-functional study execution team in support of study deliverables • Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership • Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs • Assist in preparation and review of clinical trial documentation such as; protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents • Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews • Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files • Participates in service provider selection process as a part of outsourcing activities • Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required • Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations • Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers • In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents • Manage clinical trial budgets, providing ongoing financial reporting and projections • Negotiate and finalize site contracts and budgets • Perform and manage data review process on an ongoing basis • Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed • Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues • Ensures tracking and review of protocol deviations and assesses impact on study data • Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget • Provides oversight for forecasting of clinical supplies, including study drug and supplies.