- Support the completion of all Clinical Data Management owned deliverables in order to achieve defined business goals;
- Participate in designing and building of clinical studies database using electronic data capture platforms;
- Design, manage and document required database validation (user acceptance testing);
- 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;
- Generate and maintain all required documentation related to database release, maintenance and closure, including database specifications, validation efforts, database release, edit check procedures, import/export setup, and processing;
- Assist with the development of Data Management Plans, Data Entry Guidelines and database training documentation;
- Train clinical centers on quality clinical data capture;
- Manage database user access;
- 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
- Bachelor's or Associate's Degree
- Minimum of one to three years of related experience, ideally in a clinical research environment.
- Understanding of the use of electronic database tools, systems, and coding dictionaries.
- Science or Math Degree
- Experience working with statistical programs (eg. SAS, or R) and statistical modeling
- Working knowledge of how data models and database design impact data quality and reporting
- Understanding of GCP and FDA regulations (812 and 11)
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Clinical Data Specialist - Minneapolis, United States - Inspire Medical Systems I
Description
Job Description
Job DescriptionABOUT 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
This position will assist in designing, building and maintaining clinical studies databases using electronic data capture platforms 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 data analysts and clinical study managers to provide input for all data management related activities.
OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
Required Qualifications
Preferred Qualifications
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 an equal opportunity employer 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.
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Clinical Data Specialist professionals in Minneapolis
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Kelly Brabec
Clinical Documentation Integrity Advisor, RN
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Dr. Mahad Ibrahim
MD | PGOBGYN | Healthcare Analyst