Clinical Study Manager

Inspire Medical Systems - Golden Valley, MN

Full-time - Mid Level

Golden Valley, MN

Computer and Electronic Product Manufacturing

About the position

The Clinical Study Manager 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.

Responsibilities

• Manage clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines.
• Collaborate with internal and external clinical team members and consultants to draft clinical study protocols and other clinical 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.
• Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports.
• 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 through the study.
• Oversee investigational device allocation, distribution and reconciliation.
• Collaborate with data management team to ensure appropriate data capture, query management and to identify data analysis needs.
• Use critical thinking skills to review and analyze scientific journal articles.
• Assist with generation and/or review of study-related abstracts, posters, presentations, manuscripts as needed.

Requirements

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

Nice-to-haves

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

Benefits

• Multiple health insurance plan options
• Employer contributions to Health Savings Account
• Dental, Vision, Life and Disability benefits
• 401k plan + employer match
• Identity Protection
• Flexible time off
• Tuition Reimbursement
• Employee Assistance program
• Employee Stock Purchase Program