Senior Clinical Study Manager

Job overview

The Senior Clinical Study Manager role is onsite in Minneapolis, MN. Compensation is not specified as a fixed numeric range; the posting says salary will be set based on experience and qualifications. Inspire Medical Systems develops a medical device intended to reduce obstructive sleep apnea severity for patients who cannot tolerate or consistently benefit from CPAP. The manager oversees clinical study activities and daily operations, coordinating internal and external teams to conduct studies in accordance with procedures, regulations, and guidelines. The role supports reliable study execution, participant safety oversight, data quality, and reporting.

What you'll do

• Manage clinical studies under internal procedures and applicable regulations
• collaborate on protocols and study documentation
• oversee site selection and activation
• track and report adverse events and oversee safety committees
• oversee monitoring plans, reports, schedules, and corrective actions
• develop training plans
• prepare study reports
• lead study calls and investigator meetings
• oversee investigational device allocation
• coordinate data capture and query management
• review scientific articles and support study publications
• complete quality-system documentation and training.

What we're looking for

Skills & competencies

senior clinical study manager

clinical research

minneapolis mn

inspire medical systems

clinical studies

study monitoring

patient safety

adverse event reporting

gcp

21 cfr 812

medical device

onsite

bachelor’s degree required

Work arrangement

• Weekend coverage required

Benefits & perks

• Health insurance options
• employer HSA contributions
• dental, vision, life, and disability benefits
• 401(k) with employer match
• identity protection
• flexible time off
• tuition reimbursement
• employee assistance program
• equity awards and employee stock purchase program.

Why this role

Requires a bachelor’s degree and at least five years of clinical research experience; clinical study management and international clinical experience preferred.

About the employer

Inspire Medical Systems Inc. is hiring for this role. Industry: Electromedical and Electrotherapeutic Apparatus Manufacturing. Sector: 33.