About the job
As the Clinical Operations Lead, you will play a pivotal role in overseeing the clinical operations of projects at both regional and global levels. Your responsibilities will include ensuring that project deliverables are met and that Clinical Research Associates (CRAs) and Investigator sites operate in compliance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations. You will serve as the primary communication bridge between CRAs and the clinical project team, facilitating effective collaboration and project execution.
In this dynamic role, you will conduct project-specific training for CRAs, undertake assessment visits with CRAs, and implement effective enrollment and recruitment strategies. You will also be responsible for preparing the monitoring plan and other essential documentation, as well as overseeing the scheduling of monitoring visits, evaluating site performance metrics, escalating issues, and executing corrective actions when necessary. Additionally, you will develop study tools for site and CRA utilization, review visit reports, monitor protocol deviations, and support various objectives related to clinical operations and the clinical project team.
