• Manage multiple aspects of clinical studies working under the guidance and direction of the Clinical Program Lead. • Accountable for the delivery of project(s) to achieve agreed timelines, scope, quality, and budget. • Perform oversight of CRO and auxiliary vendors; identify risks and broker solutions. • Provide support and oversight managing the creation, maintenance and close out of TMF activities. • Ensure appropriate escalation of enrollment, site activation and data collection milestones. • Support the clinical team to ensure the completeness of clinical protocol, investigator brochure, informed consent forms, clinical study reports and case report forms. • Ensure site monitoring reports are accurate and thorough, reviewed on a regular basis and that metrics are adhered to. • Support database lock by ensuring appropriate oversight of sites and by participating in data review/reconciliation efforts. • Coordinate with Clinical Supply Chain regarding drug forecasting and supply of drug product to sites. • Establish and maintain effective communication and collaboration with functional area peers to meet study/program objectives and support goals. • Lead or co-lead department initiatives to support an expanding organization. • Travel may be required (10% – 15%).