Sr. Clinical Study Manager

1 month ago

Sacramento, California, United States Inspire Medical Systems, Inc. Full time

ABOUT INSPIRE MEDICAL SYSTEMS

Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA). We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP. Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

WHY JOIN OUR FAST-GROWING TEAM

At Inspire, we value people - your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community. We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team

ABOUT THIS POSITION

We are recruiting a Senior Clinical Study Manager to join Inspire Medical Systems located in the Minneapolis, MN location. In this role, you will be a member of a small, cross functional team focusing on a strategic initiative. It will be a fast-paced environment where you will contribute to multiple different roles.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE

  • Responsible for managing clinical studies in accordance with internal standard operating procedures and applicable regulations and guidelines
  • Strategically plan, sequence, and scope clinical studies to build clinical evidence to support therapy adoption
  • Collaborate with internal and external clinical team members, consultants, and/or CROs 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 throughout 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
  • 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;
  • Build effective working relationships with team members

WHAT YOU CAN BRING TO OUR GREAT TEAM

Required:

  • Bachelor's Degree
  • Minimum of five years of related experience, ideally in a clinical research environment and/or in clinical study management.
  • Understanding of GCP and 21 CFR 812
  • Ability to work on multiple tasks concurrently with changing priorities

Preferred:

  • Experience with building clinical databases and data analysis
  • Minimum of ten years of related experience, ideally in a medical device clinical research environment
  • Experience with US and international based clinical studies

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 regarding 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 anequal opportunityemployer with recruitment efforts focused on ensuring a diverse workforce.Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at or email (dot)com

Inspire Medical Systems participates in E-Verify.



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 or email

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