Senior Clinical Study Manager

Senior Clinical Study Manager

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Inspire Medical Systems is committed to enhancing patients' lives through sleep innovation.

We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

This position is for overseeing clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills. This position may be part of a small, cross functional team or may have direct reports.

Main duties/responsibilities include managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines, collaborating with internal and external clinical team members, consultants and/or CROs to draft clinical study protocols and other clinical study documentation, overseeing clinical site selection and activation, managing study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees including Clinical Events Committees and Data Safety Monitoring Boards, overseeing monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to monitoring findings, developing training plans for study training and review/approve training documentation, preparing study-related reports including annual, interim and final study reports, organizing and leading study-related conference calls and Investigator meetings as needed through the study, overseeing investigational device allocation, distribution and reconciliation, collaborating with data management team and/or CRO to ensure appropriate data capture, query management and to identify data analysis needs, using critical thinking skills to review and analyze scientific journal articles, assisting with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed.

Quality system responsibilities include documenting product and therapy related field reports within the prescribed timelines and providing any necessary documents required to complete the investigation. Provide follow-up reporting as needed. Completing training requirements and competency confirmations as required for this position within the required timeline. Complying with applicable quality system procedures/policies and making suggestions for continuous process improvement. Ensuring all direct reports maintain training records that comply with applicable quality system requirements.

(if applicable)

Qualifications include educational requirements of a Bachelor's Degree required, and a Science Degree preferred (Biology, Chemistry, etc.). Required experience includes previous clinical research experience (minimum 5 years) required, previous clinical study management experience preferred, international clinical experience preferred, previous collaboration with physician investigators, strong knowledge of clinical research study design and study monitoring functions, understanding of GCP and 21 CFR 812, experience working with Institutional Review Boards and/or Ethics Committees, strong technical writing skills.

Salary range is $106,000 - $170,000 USD.

Inspire offers a highly competitive benefits package including multiple health insurance plan options, employer contributions to Health Savings Account, dental, vision, life and disability benefits, 401k plan + employer match, identity protection, flexible time off, tuition reimbursement, employee assistance program. All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.