Senior Clinical Study Lead

Inspire Medical Systems, Inc.; Minneapolis (MN); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Health insurance

401k match

Tuition reimbursement

Employee Stock Purchase Program

Job summary

Inspire Medical Systems is seeking a Clinical Study Manager to oversee clinical activities for multiple studies, and to manage daily in-house operations related to the studies. The role requires independence, critical thinking, and potential for direct reports in a small cross-functional team.

Key qualifications include at least 5 years in clinical research, experience with study design and monitoring, familiarity with IRBs, and strong technical writing skills.

Qualifications

• Minimum 5 years in clinical research.
• Experience managing clinical studies preferred.
• International clinical experience preferred.
• Experience with Institutional Review Boards/Ethics Committees.
• Strong technical writing skills.

Responsibilities

• Lead and manage clinical studies per SOPs and regulations.
• Draft protocols and study documentation with CROs and teams.
• Oversee site activation and monitoring.
• Track adverse events and safety oversight committees.
• Prepare interim and final study reports and analyses.
• Coordinate investigator meetings and study communications.
• Oversee device allocation and data management collaborations.
• Review scientific articles and contribute to abstracts and posters.

Skills

Clinical research

Study management

International experience

GCP/21 CFR 812

Technical writing

Education

Bachelor's degree

Science degree (preferred)

Job description

Inspire Medical Systems is seeking a Clinical Study Manager to oversee clinical activities for multiple studies, and to manage daily in-house operations related to the studies. The role requires independence, critical thinking, and potential for direct reports in a small cross-functional team.

Key qualifications include at least 5 years in clinical research, experience with study design and monitoring, familiarity with IRBs, and strong technical writing skills.