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