Senior Clinical Study Manager
Inspire Medical Systems, Inc. is a medical technology company dedicated to developing innovative solutions for patients with obstructive sleep apnea (OSA). The Senior Clinical Study Manager will oversee clinical activities related to one or more clinical studies, ensuring compliance with internal standard operating procedures and applicable regulations. This role involves managing daily in-house operations associated with the studies and may include leading a small, cross-functional team or having direct reports.
Key responsibilities include collaborating with internal and external clinical team members, consultants, and/or contract research organizations (CROs) to draft clinical study protocols and other related documentation. The manager will oversee clinical site selection and activation, track and report adverse events, and manage monitoring activities related to assigned clinical studies. Additional duties involve developing training plans, preparing study-related reports, organizing study-related conference calls and investigator meetings, and overseeing investigational device allocation, distribution, and reconciliation.
Candidates should possess a Bachelor's Degree, preferably in a science-related field such as Biology or Chemistry. A minimum of five years of clinical research experience is required, with previous clinical study management experience preferred. International clinical experience and prior collaboration with physician investigators are advantageous. Strong knowledge of clinical research study design, study monitoring functions, Good Clinical Practice (GCP), and 21 CFR 812 is essential. Experience working with Institutional Review Boards and/or Ethics Committees, along with strong technical writing skills, is also necessary.
Inspire Medical Systems offers a comprehensive benefits package, including 401(k) matching, Employee Stock Purchase Plan (ESPP), flexible time off (FTO), and tuition reimbursement. The company fosters a people-first culture, valuing diverse experiences and backgrounds, and encourages learning opportunities to build a professional network that grows into a community. Employees are committed to enhancing patients' lives through sleep innovation, prioritizing patient outcomes, acting with integrity, and leading with respect.
Joining Inspire Medical Systems provides an opportunity to be part of a fast-growing team dedicated to revolutionizing the sleep industry with FDA-approved medical devices designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP therapy. The company is steadfast in its commitment to prioritize patient outcomes and offers a collaborative environment for professional growth.