SI-BONE, Inc

Role Description The CSM is a hands-on individual contributor responsible for the end-to-end execution of SI-BONE’s clinical studies, including project management, site management, and study data leadership. - Direct responsibility for study management activities from study start-up to close-out. - Oversee site monitoring activities, including direct monitoring, site performance management, and risk-based oversight. - Collaborate with the clinical team and cross-functionally with Regulatory, Medical Affairs, R&D, and other stakeholders. - Maintain strong relationships with investigative sites and physician partners. - Ensure compliance with worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual. - Act and conduct company business in an honest, ethical and lawful manner. Qualifications - Knowledge of medical terminology. - Basic understanding of summary statistics with the ability to interpret data meaningfully. - 4+ years clinical research experience, or advanced degree with experience working with nurses and physicians. - Bachelor’s degree; Advanced degree in health science field preferred. - Travel fluency. Requirements - Lead and support all phases of clinical study execution with a strong emphasis on site management and data quality oversight. - Conduct site qualification, initiation, interim monitoring, and close out visits (remote or on-site). - Perform data monitoring and source data review, ensuring data quality and protocol compliance. - Serve as the primary contact, providing training to sites on protocol, processes, systems, and study requirements. - Oversee EDC development and maintenance, including CRF design and database configuration. - Manage and maintain essential regulatory and study documents, ensuring they are complete, accurate, and audit-ready. - Drive the development of study-related materials, including CRFs, ICFs, and Clinical Monitoring Plans. - Maintain knowledge of the therapeutic area and clinical best practices. - Support the SI-BONE Quality System. Benefits - Salary range: $85,000 - $96,000 (California - SF Bay Area). - Supplemental pay: bonus and stock.