Senior Clinical Study Lead for Medical Device Trials

Inspire Medical Systems; Minneapolis (MN); On-site; USD 106,000 - 145,000; Full time

Benefits offered by this job

Health insurance

401k matching

Tuition reimbursement

Employee Assistance Program

Equity participation

Job summary

Inspire Medical Systems is seeking a Clinical Study Manager to oversee clinical activities for one or more studies and run daily in-house operations. You will work independently across complex studies within a cross-functional team and may have direct reports.

The role requires 5+ years in clinical research, knowledge of GCP, and experience with IRBs. The position emphasizes collaboration with CROs and internal teams to ensure high-quality study execution.

Qualifications

• Minimum 5 years clinical research experience.
• Experience with Institutional Review Boards (IRBs) and Ethics Committees.
• Strong knowledge of GCP and 21 CFR 812.

Responsibilities

• Manage clinical studies per SOPs and regulatory guidelines.
• Draft protocols and documentation with internal team/CROs.
• Oversee site activation and monitoring activities.
• Track adverse events and safety reporting to regulatory bodies.
• Prepare annual, interim and final study reports.
• Organize investigator meetings and study-related calls.

Skills

Clinical research

Study management

Regulatory knowledge

GCP

IRB/EC experience

Education

Bachelor's Degree

Science Degree preferred

Job description

Inspire Medical Systems is seeking a Clinical Study Manager to oversee clinical activities for one or more studies and run daily in-house operations. You will work independently across complex studies within a cross-functional team and may have direct reports.

The role requires 5+ years in clinical research, knowledge of GCP, and experience with IRBs. The position emphasizes collaboration with CROs and internal teams to ensure high-quality study execution.