• 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.