Unclassified - Northbrook, IL
posted 3 months ago
The Clinical Site Manager (CSM) plays a crucial role in the management of clinical trials, serving as the primary contact point between the Sponsor and the Investigational Site. This position is essential for ensuring that trial sites are inspection-ready and compliant with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations from the start of the study through to site closure. The CSM is responsible for managing the site/sponsor relationship, ensuring effective communication and support throughout the clinical trial process. In this role, the CSM will collaborate closely with various stakeholders, including the Clinical Trial Lead (CTL), Clinical Trial Manager (CTM), Clinical Trial Specialist (CTS), and Study Start-Up Specialist (SSS), to ensure comprehensive site management and the successful execution of trial-related activities. Responsibilities include site selection, pre-trial assessments, recruitment and retention strategies for study participants, site activation and initiation, on-site and remote monitoring, and overall relationship management with the site. The CSM will also be involved in close-out activities, ensuring that all aspects of the trial are completed in accordance with regulatory requirements and company policies. The CSM is expected to develop meaningful relationships with site staff through consistent communication and engagement, participate in investigator meetings, and may serve as the Lead CSM for specific studies, providing oversight and support to other CSMs. This role requires a proactive approach to site management, including the implementation of risk-based monitoring strategies, ensuring site compliance with study protocols, and maintaining accurate and complete documentation throughout the trial phases. The CSM will also be responsible for training site staff and ensuring that all necessary supplies and documentation are in place for the successful conduct of the trial.