• 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.

• Oversee and manage clinical trial projects • Collaborate with cross-functional teams to ensure project success • Ensure compliance with regulatory and company standards • Develop and maintain project timelines and budgets

• Identifying and anticipating potential issues impacting business goals • Leading global initiatives and working groups • Collaborating with study teams to ensure quality compliance • Designing study documents to ensure quality by design • Developing risk identification and management strategies • Consulting on business initiatives and tools for compliance • Maintaining expertise in global GCP guidance and regulations • Conducting quality issue trending and root cause analysis

• Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project. • Apply principles, concepts and techniques for effective and proactive project management of a clinical study. • Balances resource constraints (i.e. time, money, people, and equipment) against deliverables. • Develop clinical study budget and may assist in quarterly departmental budget reviews. • Seeks input from higher-level clinical experts or program management as issues warrant. • Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department. • Implement and maintain risk-based monitoring processes to drive efficient and effective study management. • Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance. • Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance.