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 will assist in designing, building and maintaining clinical studies database using electronic data capture platforms; interpreting, analyzing and reporting clinical data; and generating required documentation related to data management, while ensuring compliance with GCPs, FDA regulations and SOP requirements. This person will work directly with clinical management and clinical study managers to provide input for all data management related activities.

MAIN DUTIES AND RESPONSIBILITIES

• • Build effective working relationships with team members.
  • Support the completion of all Clinical Data Management owned deliverables in order to achieve defined business goals;
  • Review and provide feedback on study protocols, Statistical Analysis Plans, etc.
  • Participate in the designing and building of clinical studies database using electronic data capture platforms;
  • Proactively organize and perform on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues;
  • Complete and document required testing and validation of the clinical study within the database;
  • Use statistical and analytical skills to organize, analyze and illustrate clinical data;
  • Generate and maintain all required documentation, including the development of specifications and validation efforts in support of annotated Case Report Forms (CRFs), database creation, edit check procedures, import/export setup, and processing;
  • Assist in training clinical centers on quality clinical data capture;
  • Ensure proper closeout and archiving of data management study related materials, i.e. database change documentation, validation documents, and final patient casebooks in paper or electronic format;
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and Work Instructions related to data management activities;

QUALITY SYSTEM RESPONSIBILITIES

• • Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
  • Complete training requirements and competency confirmations as required for this position within the required timeline.
  • Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.

QUALIFICATIONS

• Educational Requirements:
  • Bachelor’s Degree in related field required (mathematics or statistics degree preferred)
  • Master’s Degree preferred
• Required Experience:
  • Previous clinical data management or related experience (minimum 2 years) preferred
  • Working knowledge of how data models and database design impact data quality and reporting is required.
  • Strong analytical skills with the ability to collect, organize, analyze and disseminate significant amounts of data with strong attention to detail and accuracy is an essential function of this position.
  • Experience working with statistical programs (eg. SAS, or R) and statistical modeling is preferred
  • Must be self-motivated and adaptable to learning and understanding new technologies
  • Must be able to prioritize and manage multiple tasks
  • Must have strong analytical, problem-solving, and decision-making capabilities
  • Must have the ability to work both independently and in a collaborative team environment
  • Strong knowledge of clinical research study design and analysis is essential
  • Understanding of GCP and FDA regulations (812 and 11)

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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