Clinical Site Manager (CSM) – Data Management Lead

SI-BONE, Inc•Santa Clara, CA

6d•Remote

About The Position

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. The Clinical Site Manager (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. This role has direct responsibility for study management activities from study start-up to close-out, including site management, data management activities, EDC development, and delivery of high-quality, inspection-ready data. The CSM will oversee site monitoring activities, including direct monitoring, site performance management, and risk-based oversight, while ensuring protocol compliance and accurate, complete datasets. The CSM collaborates with the clinical team and cross-functionally with Regulatory, Medical Affairs, R&D, and other stakeholders to support study planning, execution, and development of study materials. This role also maintains strong relationships with investigative sites and physician partners to support high-quality study conduct and alignment with clinical and business objectives. Responsible for performing all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual. The employee must act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s Code of Conduct, other company policies and the AdvaMed Code of Conduct and/or any other applicable industry code(s) of conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations.

Requirements

Knowledge of medical terminology
Basic understanding of summary statistics with the ability to interpret data in a meaningful way
Agile and able to change direction as needed
Ability to identify and solve problems independently
4+ years clinical research experience, or advanced degree with experience working with nurses and physicians
Bachelor’s degree
Travel fluency
Self-starter is a must for this position
Friendly outgoing personality who can build trust and rapport with spine surgeons and study coordinators
Organized and efficient, this person should be a true team player with excellent verbal and written communication skills.
Knowledge and familiarity of applicable regulations/standards (e.g. ISO 14155, ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971) as required to perform the job function

Nice To Haves

Advanced degree in health science field preferred
Writing sample (monitoring report and follow up letter) required for review

Responsibilities

Lead and supports 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, and site performance, including data entry timeliness, query resolution, and patient recruitment to ensure data quality and protocol compliance
Serve as the primary contact, providing training to sites on protocol, processes, systems, and study requirements
Ensures high quality data by acting as the study protocol expert and key site resource for questions
Oversee EDC development and maintenance, including CRF design, database configuration, and edit checks throughout study lifecycle
Support site selection and feasibility, including investigator qualification and recruitment assessment.
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, in collaboration with cross-functional teams
Maintain knowledge of the therapeutic area and clinical best practices
Perform additional study-related responsibilities as needed
Support the SI-BONE Quality System