Senior Clinical Study Manager

Regulatory Toolkit; Minneapolis (MN); Presencial; USD 140.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401k matching

Employee stock purchase program

Equity awards

Tuition reimbursement

Flexible time off

Disability benefits

Descripción de la vacante

Inspire Medical Systems in Minnesota seeks a Clinical Study Manager to oversee one or more clinical studies and manage daily in-house study operations. The role requires independent work on complex studies within a cross-functional team, with potential direct reports.

You will collaborate with internal and external teams, draft study protocols, monitor safety, manage site activation, training, and study reports, ensuring compliance with regulatory standards.

Formación

• Bachelor’s degree required.
• Science background preferred (Biology, Chemistry).
• Experience in clinical research and study design.

Responsabilidades

• Manage clinical studies per SOPs and regulations.
• Draft protocols with internal/external teams.
• Oversee site activation and monitoring activities.
• Track adverse events and safety committees.
• Prepare annual and final study reports.
• Lead investigator calls and meetings as needed.

Conocimientos

Clinical research experience

Clinical study management

GCP and 21 CFR 812 knowledge

Technical writing

IRB/EC experience

Educación

Bachelor’s Degree

Science Degree preferred

Descripción del empleo

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. Inspire Medical Systems is committed to enhancing patients’ lives through sleep innovation. We are steadfast in our commitment to prioritize patient outcomes, act with integrity and lead with respect. With positive persistence at our core, we are committed to all those we serve.

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 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!

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. This position may be part of a small, cross functional team or may have direct reports.

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, 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 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 and/or CRO 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

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.
• Ensure all direct reports maintain training records that comply with applicable quality system requirements. (if applicable)

QUALIFICATIONS

Educational Requirements:

• Required: Bachelor’s Degree required
• Preferred: Science Degree preferred (Biology, Chemistry, etc.)

Required Experience:

• Previous clinical research experience (minimum 5 years) required
• Previous clinical study management experience preferred
• 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

The salary for this position will be offered at a level consistent with the experience and qualifications of the candidate. This information reflects the anticipated salary range for this position at the time of posting. The salary range may be modified in the future and actual compensation may vary from the posting based on various factors such as geographic location, work experience, education and/or skill level.

Salary

$140,000—$180,000 USD

BENEFITS AND OTHER COMPENSATION

Inspire offers a highly competitive benefits package including (general description of the benefits and other compensation offered):

• 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.
• All employees have the opportunity to participate in the ownership and success of Inspire. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

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, pregnancy or childbirth, 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. Inspire Medical Systems participates in E-Verify.