Senior Clinical Studies Leader

Inspire Medical Systems I; Minneapolis (MN); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401k match

ESPP

Flexible time off

Tuition reimbursement

Employee assistance

Job summary

Inspire Medical Systems in Minneapolis, MN seeks a Clinical Study Manager to oversee multiple clinical studies, manage daily in-house study operations, and ensure compliance with regulatory standards. The role requires independent work, critical thinking, and collaboration with internal teams, CROs, and investigator sites.

The ideal candidate has at least 5 years in clinical research, strong technical writing skills, and experience with protocol development and safety monitoring.

Qualifications

• Minimum 5 years of clinical research experience.
• Experience managing clinical studies.
• International clinical experience preferred.
• Collaboration with physician investigators.
• Strong knowledge of GCP and 21 CFR 812.
• Experience working with IRBs/ECs.
• Strong technical writing skills.

Responsibilities

• Manage clinical studies in accordance with SOPs and regulations.
• Draft study protocols and related documentation with CROs and teams.
• Oversee site selection and activation for studies.
• Monitor safety through adverse event tracking and reporting.
• Review monitoring plans and ensure corrective actions.
• Develop training plans and approve training documentation.
• Prepare annual, interim, and final study reports.
• Lead study-related calls and investigator meetings.
• Coordinate investigational device allocation and distribution.
• Collaborate with data management to ensure data capture and analysis needs.
• Review scientific articles to support study activities.
• Assist with abstracts, posters, and manuscripts as needed.

Skills

Clinical research experience

Clinical study management

International experience

Collaboration with investigators

GCP & 21 CFR 812 knowledge

IRB/EC experience

Technical writing

Education

Bachelor’s Degree

Job description

Inspire Medical Systems in Minneapolis, MN seeks a Clinical Study Manager to oversee multiple clinical studies, manage daily in-house study operations, and ensure compliance with regulatory standards. The role requires independent work, critical thinking, and collaboration with internal teams, CROs, and investigator sites.

The ideal candidate has at least 5 years in clinical research, strong technical writing skills, and experience with protocol development and safety monitoring.