Senior Clinical Study Lead – Medical Devices

Regulatory Jobs; Minneapolis (MN); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401k matching

Employee stock purchase program

Equity awards

Tuition reimbursement

Flexible time off

Disability benefits

Job summary

Inspire Medical Systems in Minnesota seeks a Clinical Study Manager to oversee one or more clinical studies and manage daily in-house study operations. The role requires independent work on complex studies within a cross-functional team, with potential direct reports.

You will collaborate with internal and external teams, draft study protocols, monitor safety, manage site activation, training, and study reports, ensuring compliance with regulatory standards.

Qualifications

• Bachelor’s degree required.
• Science background preferred (Biology, Chemistry).
• Experience in clinical research and study design.

Responsibilities

• Manage clinical studies per SOPs and regulations.
• Draft protocols with internal/external teams.
• Oversee site activation and monitoring activities.
• Track adverse events and safety committees.
• Prepare annual and final study reports.
• Lead investigator calls and meetings as needed.

Skills

Clinical research experience

Clinical study management

GCP and 21 CFR 812 knowledge

Technical writing

IRB/EC experience

Education

Bachelor’s Degree

Science Degree preferred

Job description

Inspire Medical Systems in Minnesota seeks a Clinical Study Manager to oversee one or more clinical studies and manage daily in-house study operations. The role requires independent work on complex studies within a cross-functional team, with potential direct reports.

You will collaborate with internal and external teams, draft study protocols, monitor safety, manage site activation, training, and study reports, ensuring compliance with regulatory standards.