• Contribute to one or multiple clinical studies and demonstrate thorough knowledge of clinical operations project management. Collaborate with cross-functional clinical study team to support clinical study delivery. • Evaluates, and ensures appropriate oversight of CROs and other external vendors. • Ensure clinical trials are executed according to scope of work, budget, timelines, KPIs, and corporate goals. • Establish and maintain effective communication and collaboration with functional area peers to meet clinical study objectives and support goals. • Identify risks and propose solutions to facilitate clinical studies. • Responsible for review and oversight of the study-level budget(s) and demonstrates accountability for the management of the budgets through managing the review and approval of contracts and/or work order changes; contribute to budget forecasting and accruals in collaboration with finance. • Oversee and manage the creation, maintenance, QC and close out of TMF activities. • Ensure appropriate oversight of enrollment, site activation and data collection milestones. • Contribute to and support team to ensure the completeness of study documents including, study protocol, investigator brochure, informed consent forms, clinical study reports and case report forms. • Collaborate with Data Management to ensure timely and efficient database lock. Participate in data review and reconciliation efforts. • Lead or co-lead department initiatives to support an expanding organization.