
11 - 50 employees
🏭 Manufacturing
🏥 Healthcare
💊 Pharmaceuticals
Manufacturing • Healthcare • Pharmaceuticals
Shoulder Innovations is a medical device company that specializes in innovative solutions for shoulder replacement, most notably through its core technology, the InSet™ Glenoid. The company focuses on enhancing the longevity and effectiveness of glenoid fixation techniques, recognizing that traditional methods often fall short. Their approach aims to revolutionize shoulder arthroplasty and significantly improve patient outcomes.
🔥 1 minute ago
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11 - 50 employees
🏭 Manufacturing
🏥 Healthcare
💊 Pharmaceuticals
Manufacturing • Healthcare • Pharmaceuticals
Shoulder Innovations is a medical device company that specializes in innovative solutions for shoulder replacement, most notably through its core technology, the InSet™ Glenoid. The company focuses on enhancing the longevity and effectiveness of glenoid fixation techniques, recognizing that traditional methods often fall short. Their approach aims to revolutionize shoulder arthroplasty and significantly improve patient outcomes.
• Provide comprehensive administrative support for clinical trial operations, including organizing, maintaining, and updating study documentation within the Trial Master File (TMF) • Manage documentation processes to meet regulatory and compliance requirements and Good Clinical Practice (GCP) standards • Assist with preparation, review, and submission of Institutional Review Board (IRB) documents • Monitor adherence to study protocols and regulatory guidelines, identifying and addressing compliance gaps • Support day-to-day trial operations and collaborate with cross-functional teams to resolve operational issues • Track and manage study data, including Case Report Forms (CRFs), ensuring data integrity and timely system entry • Monitor trial progress and performance metrics, communicate with study sites, draft status reports, and escalate issues • Coordinate site communications and serve as a point of contact for inquiries and updates • Perform additional tasks assigned by the Associate Director of Clinical Affairs
• Bachelor's degree, or an equivalent combination of experience, education and training • 2+ years experience at the Sponsor or CRO level, or 5 years at the SMO or site level • Experience with medical device clinical studies preferred • Experience with shoulder arthroplasty or orthopedics a benefit but not essential • Familiarity with clinical development standards and regulatory requirements (GCP, FDA) • Knowledge of current industry standards (e.g., GCP, ICH, CDISC/CDASH) • Proficiency with Microsoft Office (Excel, Word); strong Excel skills required • Experience working in cross-functional, multi-site clinical trial teams
• Great company culture • Opportunities for professional growth • Competitive wages • Benefits
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