Clinical Research Manager
$125,500–$153,400 year
On-siteBrea, California, United States or Pomona, California, United States
Job Summary
Design, organize, and execute clinical usability studies for dental products in Restorative, Endodontics, and Preventive categories while managing vendor relationships with finance and legal. Develop design validation protocols, prepare IRB approval documents, and audit Informed Consent Forms and Case Report Forms. Analyze study results, generate reports, and maintain study databases to track status updates. Collaborate with marketing, R&D, and clinical teams to support new product development, innovation pipeline evaluation, and successful launches. Create and update Instructions for Use, Risk Management Files, and Clinical Evaluation Reports to ensure compliance with FDA, ISO 14155, and EU MDR regulations.
Required Qualifications
- Doctor of Dental Science (DDS) or similar degree
- 5 years of relevant dental experience
- Must reside within a commutable distance to Brea, CA or Pomona, CA
- Ability to travel domestically and internationally
- Experience supporting compliance with FDA, ISO 13485, MDSAP, EU MDR, and GMP
- Ability to work in a diverse team
- Prioritizing and planning own workload
- Experience using Microsoft Office (Word, Excel, Power Point) to prepare charts, tables, forms, reports, and presentations
Desired Qualifications
- Dentist or Hygienist
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