Senior Clinical Study Manager

The role

The Senior Clinical Study Manager oversees clinical activities for one or more clinical studies and manages daily in-house operations. This role involves managing studies in accordance with internal procedures and regulations while working independently or within a cross functional team.

What you will do

• 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 clinical study documentation
• Oversee clinical site selection and activation
• Manage study safety by tracking and reporting adverse events and overseeing safety committees
• Oversee monitoring activities 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
• Oversee investigational device allocation, distribution and reconciliation
• Collaborate with data management team and/or CRO to ensure appropriate data capture and query management

Required qualifications

• Bachelor’s Degree
• Minimum 5 years of previous clinical research experience
• Previous collaboration with physician investigators
• 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 have

• Science Degree (Biology, Chemistry, etc.)
• Previous clinical study management experience
• International clinical experience

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
• Equity awards
• Employee Stock Purchase Program

About the company

Inspire Medical Systems is a medical device company designed to reduce OSA severity. They are committed to enhancing patients' lives through sleep innovation.