New · posted Oct 31
Inspire Medical Systems · Medical Devices
Senior Clinical Study Manager
- Minneapolis, MN
- On-site
- Full-time
- Manager
The role
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.
What you need
Educational Requirements
- Required: Bachelor’s Degree required
- Preferred: Science Degree preferred (Biology, Chemistry, etc.)
Required Experience
- 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
The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.
Salary
$140,000—$180,000 USD
What you'll do
MAIN DUTIES/RESPONSIBILITIES
- Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines
- Collaborate with internal and external clinical team members, consultants and/or CROs to draft clinical study protocols and other clinical study documentation
- Oversee clinical site selection and activation
- Manage 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
- Oversee 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
- Develop training plans for study training and review/approve training documentation
- Prepare study-related reports including annual, interim and final study reports
- Organize and lead study-related conference calls and Investigator meetings as needed through the study
- Oversee investigational device allocation, distribution and reconciliation
- Collaborate with data management team and/or CRO to ensure appropriate data capture, query management and to identify data analysis needs
- Use critical thinking skills to review and analyze scientific journal articles
- Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed
QUALITY SYSTEM RESPONSIBILITIES
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Ensure all direct reports maintain training records that comply with applicable quality system requirements. (if applicable)
Pay and benefits
$140,000 – $180,000 a year
Employer providedWHY JOIN OUR FAST-GROWING TEAM
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.
At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.
If you’re passionate about making a difference in people’s lives and want to work with innovative technology, come be a part of our great team!
Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):
Where you'll work
Minneapolis, MNOn-siteOpen in Maps (opens in a new tab)
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From the posting
About Inspire
ABOUT INSPIRE MEDICAL SYSTEMS
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.
Equal opportunity, accessibility and legal noticesInspire Medical Systems's statements, word for word
Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, pregnancy or childbirth, or any other status protected by applicable federal, state, and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.
Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at 844-672-4357 or email careers@inspiresleep(dot)com
Inspire Medical Systems participates in E-Verify.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Clinical Trial Management roles at this level.
This roleEmployer provided
Manager roles in the US26 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $140,000 | — | $180,000 |
| All US (middle half) | $150,000 | $162,000 | $175,000 |
This role: Inspire Medical Systems's own published range. Comparisons: the base pay employers published on open Clinical Trial Management roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Trial Management
The general path across 33 open Clinical Trial Management roles on Regulatory Jobs, with the titles they carry most. Not Inspire's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct12
- Documentation and SOPs10
- Collaboration and leadership8
- Investigations and CAPA4
- GMP and compliance2
- Quality systems and risk2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Inspire on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 2
- Locations
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Senior Clinical Study Manager at Inspire
Open until filled. $140K–$180K a year, employer provided.