Senior Clinical Study Leader for Sleep Innovation

Inspire Medical Systems, Inc.; Minneapolis, Northern (MN, KY); Hybrid; USD 106,000 - 170,000; Full time

Benefits offered by this job

Health insurance

401k plan with employer match

Employee Stock Purchase Program

Tuition Reimbursement

Flexible time off

Job summary

Inspire Medical Systems seeks a Clinical Study Manager to oversee one or more clinical studies and manage daily in-house operations. The role involves independent work on complex studies, coordinating with internal teams and CROs to ensure protocols, approvals, and reporting are completed on time.

Candidates should have at least 5 years of clinical research experience, a Bachelor's degree, knowledge of GCP and 21 CFR 812, and strong technical writing skills.

Qualifications

• Bachelor’s Degree required.
• Minimum 5 years of clinical research experience.
• Experience in clinical study management.
• Knowledge of GCP and 21 CFR 812.
• Experience with Institutional Review Boards/Ethics Committees.
• Strong technical writing skills.
• International clinical experience preferred.

Responsibilities

• Oversee clinical studies in accordance with SOPs and regulations.
• Draft protocols and study documents with internal teams and CROs.
• Oversee site selection, activation, and monitoring.
• Manage safety reporting and data review per regulatory requirements.
• Coordinate training plans and training documentation.
• Prepare annual, interim, and final study reports.
• Lead Investigator meetings and study-related calls as needed.
• Oversee device allocation, distribution, and reconciliation.
• Collaborate with data management to ensure data quality and analysis needs.

Skills

Clinical research experience

Clinical study management

GCP knowledge

21 CFR 812 knowledge

IRB/EC experience

Technical writing

International clinical experience

Education

Bachelor’s Degree

Job description

Inspire Medical Systems seeks a Clinical Study Manager to oversee one or more clinical studies and manage daily in-house operations. The role involves independent work on complex studies, coordinating with internal teams and CROs to ensure protocols, approvals, and reporting are completed on time.

Candidates should have at least 5 years of clinical research experience, a Bachelor's degree, knowledge of GCP and 21 CFR 812, and strong technical writing skills.