Clinical Study Manager

Unclassified - Golden Valley, MN

Full-time - Senior

Golden Valley, MN

About the position

The Clinical Study Manager at Inspire Medical Systems is responsible for overseeing clinical activities related to one or more clinical studies, ensuring compliance with internal procedures and regulatory guidelines. This role involves managing daily operations of clinical studies, collaborating with various teams, and utilizing critical thinking skills to navigate complex clinical environments. The position emphasizes patient outcomes and integrity, aligning with the company's mission to innovate in the sleep industry.

Responsibilities

• Manage clinical studies in accordance with internal standard operating procedures and applicable regulations.
• Collaborate with internal and external clinical team members to draft clinical study protocols and documentation.
• Oversee clinical site selection and activation.
• Manage study safety by tracking and reporting adverse events, reviewing trends, and overseeing safety committees.
• Oversee monitoring activities related to assigned clinical studies, including review and approval of monitoring plans and reports.
• Develop training plans for study training and review/approve training documentation.
• Prepare study-related reports including annual, interim, and final reports.
• Organize and lead study-related conference calls and Investigator meetings as needed.
• Oversee investigational device allocation, distribution, and reconciliation.
• Collaborate with data management team to ensure appropriate data capture and identify data analysis needs.

Requirements

• Bachelor's Degree required.
• Minimum 5 years of clinical research experience required.
• Previous clinical study management experience preferred.
• Strong knowledge of clinical research study design and monitoring functions.
• Understanding of Good Clinical Practice (GCP) and 21 CFR 812.
• Experience working with Institutional Review Boards and/or Ethics Committees.
• Strong technical writing skills.

Nice-to-haves

• Science Degree preferred (Biology, Chemistry, etc.).
• International clinical experience preferred.
• Previous collaboration with physician investigators.

Benefits

• Health savings account
• Employee stock purchase plan
• Health insurance
• Dental insurance
• Tuition reimbursement
• Employee assistance program
• Vision insurance
• 401(k) matching