United States onlySI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy.
Hiring Manager: Clinical Affairs Manager
Preferred Location: Remote - East or Centrally located
Travel: Up to 75%
General Responsibilities:
The Clinical Specialist 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 Clinical Specialist will oversee site monitoring activities, including direct monitoring, site performance management, and risk-based oversight, while ensuring protocol compliance and accurate, complete datasets.
The Clinical Specialist 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.
Specific Responsibilities and Skills:
- 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
Knowledge, Education, and Experience:
- 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, Advanced degree in health science field preferred
- Travel fluency
Expertise and Attributes:
- 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. Writing sample (monitoring report and follow up letter) required for review
- 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
Salary range: The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position considering the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.
$85,000- $96,000 (California - SF Bay Area)
Supplemental pay: bonus and stock
There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks.
We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain “@si-bone.com” to communicate with candidates.
If you believe you’ve been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.
AU, CA + 3 more