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Clinical Study Manager

Golden Valley, MN
Inspire Medical Systems, Inc. has developed the only FDA-approved neurostimulation technology that transforms the lives of people with moderate to severe sleep apnea. We are a ground-breaking, fast-growing company where the patient’s outcome is first and foremost our top priority. If you want to be part of a purpose-driven company and directly help to transform lives, this is the perfect opportunity for you!

POSITION SUMMARY
 
This position is for overseeing clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager must be able to work independently on multiple complex clinical studies using critical thinking skills.

MAIN DUTIES/RESPONSIBILITIES
 
  • Responsible for managing 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, Instructions for Use, Report of Prior Investigations, Investigational Brochures 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 including Clinical Events Committees and Data Safety Monitoring Boards
  • Oversee monitoring activities related to assigned clinical studies including review and approval of monitoring plan and monitoring reports, managing monitoring schedule and ensuring corrective action related to 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 through the study
  • Oversee investigational device allocation, distribution and reconciliation
  • Collaborate with data management team to ensure appropriate data capture and query management
  • Assist with and/or perform data analysis
  • 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

QUALIFICATIONS
 
Educational Requirements:
Required:
  • Bachelor’s Degree required
Preferred:
  • Master’s Degree preferred
  • Science Degree preferred (Biology, Chemistry, etc.)
Required Experience:
  • Previous clinical research experience (minimum 5 years) and clinical study management (minimum 2 years) required
  • International clinical experience preferred
  • 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 

Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status with regard to public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state and local laws. This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training and social and recreational programs. Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities. All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce. Applicants with a disability that are in need of accommodations to complete the Inspire Medical Systems application process should contact Human Resources at 763-235-6742 or email careers@inspiresleep.com.

Inspire Medical Systems participates in E-Verify.
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