Clinical Research Manager
Core
Managing US clinical usability studies for dental products (Restorative, Endodontics, Preventive) to ensure regulatory compliance and support new product development.
Role type
Clinical Research Manager (Medical Devices)
Builds
Clinical Evaluation Reports, Post-Market Clinical Follow-Up protocols, Instructions for Use, Risk Management Files
Domain
Medical Devices / Dental / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design and execute clinical studies per GCP/ISO 14155, Develop design validation protocols, Analyze study results and generate reports, Prepare clinical investigation documents for IRB, Select clinical study sites and investigators, Review Informed Consent Forms and Case Report Forms, Train personnel for study execution, Manage study databases, Create Risk Management Files per ISO 14971, Write Instructions for Use, Collaborate on 510k submission and CE tech files
Preferred skills
Dentist or Hygienist background, Experience with FDA/ISO 13485/MDSAP/EU MDR/GMP compliance
Technologies
Microsoft Office (Word, Excel, PowerPoint), Databases, Spreadsheets
Responsibilities
Design, organize, and execute clinical studies for new and existing dental products; Develop and execute design validation protocols; Analyze results and generate reports; Assist with IRB approval document preparation; Interface with clinicians and test sites; Prepare study-specific information for reporting; Design and execute Human Factor Usability studies; Support generation of Clinical Evaluation Reports and Post-Market Clinical Follow-Up protocols; Write and update Instructions for Use for dental products.
Seniority
Mid-Senior, hands-on IC