Senior Clinical Study Manager

About the Company

Inspire Medical Systems is the pioneer of a first-of-its-kind medical device designed to improve the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, which reduces OSA severity for patients who cannot tolerate or benefit consistently from CPAP. Inspire is committed to enhancing patient lives through sleep innovation, prioritizing patient outcomes, acting with integrity, and leading with respect. Our culture is built on positive persistence and a dedication to all we serve.

We value diverse experiences, backgrounds, and perspectives, fostering a people-first culture with excellent benefits, 401k matching, an Employee Stock Purchase Plan (ESPP), flexible time off (FTO), and tuition reimbursement. If you’re passionate about making a difference in people’s lives and working with innovative technology, join our growing team.

About the Role

This position oversees clinical activities for one or more clinical studies and manages the daily in-house operations associated with these studies. The Clinical Study Manager must work independently on multiple complex clinical studies, applying critical thinking skills. This role may be part of a small, cross-functional team or may include direct reports.

Responsibilities

• Manage clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines.
• Collaborate with internal and external clinical team members, consultants, and/or CROs to draft clinical study protocols and other study documentation.
• Oversee clinical site selection and activation.
• Manage study safety by tracking and reporting adverse events as required by regulatory bodies, reviewing adverse event trends, and overseeing safety committees, including Clinical Events Committees and Data Safety Monitoring Boards.
• Oversee monitoring activities related to assigned clinical studies, including review and approval of monitoring plans and reports, managing monitoring schedules, and ensuring corrective action for monitoring findings.
• Develop training plans for study training and review/approve training documentation.
• Prepare study-related reports, including annual, interim, and final study reports.
• Organize and lead study-related conference calls and Investigator meetings as needed.
• Oversee investigational device allocation, distribution, and reconciliation.
• Collaborate with the data management team and/or CRO to ensure appropriate data capture, query management, and identification of data analysis needs.
• Use critical thinking skills to review and analyze scientific journal articles.
• Assist with the generation and/or review of study-related abstracts, posters, presentations, and manuscripts.

Quality System Responsibilities

• Document product and therapy-related field reports within prescribed timelines and provide necessary documents to complete investigations.
• Provide follow-up reporting as needed.
• Complete training requirements and competency confirmations within the required timeline.
• Comply with applicable quality system procedures/policies and suggest improvements for continuous process enhancement.
• Ensure all direct reports maintain training records that comply with applicable quality system requirements (if applicable).

Qualifications

• Educational Requirements:
  • Required: Bachelor’s Degree.
  • Preferred: Science Degree (e.g., Biology, Chemistry).
• Experience:
  • Previous clinical research experience (minimum 5 years).
  • Previous clinical study management experience preferred.
  • International clinical experience preferred.
  • Previous collaboration with physician investigators.
• Skills & Knowledge:
  • Strong knowledge of clinical research study design and study 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.

Pay

The salary for this position is $106,000—$145,000 USD, offered at a level consistent with the candidate’s experience and qualifications. The range may be adjusted based on factors such as geographic location, work experience, education, and skill level.

Benefits

• Multiple health insurance plan options with employer contributions to a Health Savings Account.
• Dental, vision, life, and disability benefits.
• 401k plan with employer match.
• Identity protection.
• Flexible time off (FTO).
• Tuition reimbursement.
• Employee Assistance Program.
• Opportunity to participate in equity awards and the Employee Stock Purchase Program (ESPP).