Quality Review Specialist

Precision Medicine Group

Remote, United States
Remote
Periodic tmf quality reviews
Microsoft office package fluency
Etmf systems experience
Precision Medicine Group is seeking a Quality Review Specialist responsible for conducting periodic quality reviews of Trial Master Files (TMFs) for smaller studies. The ideal candidate should have a bachelor's degree, experience with eTMF systems, and knowledge of FDA & ICH/GCP regulations

Job Summary

  • The Quality Review Specialist is responsible for performing periodic TMF Quality Reviews to ensure study files are maintained in an audit-ready manner.
  • Candidates must possess established experience with eTMF systems and a working knowledge of FDA and ICH/GCP regulations.
  • The role involves monitoring document processing issues, escalating inconsistencies, and supporting updates to expected documents within the TMF.

Matching Summary

Match Score: 85

Precision Medicine Group is seeking a Quality Review Specialist responsible for conducting periodic quality reviews of Trial Master Files (TMFs) for smaller studies. The ideal candidate should have a bachelor's degree, experience with eTMF systems, and knowledge of FDA & ICH/GCP regulations.

Skills & Requirements

Must-have

  • Periodic TMF Quality Reviews
  • Microsoft Office package fluency
  • eTMF systems experience
  • FDA & ICH/GCP regulations knowledge

Nice-to-have

  • Strong interpersonal communication skills
  • Ability to identify training needs
  • Self-motivated and detail-oriented
  • Effective issue escalation capabilities

Key Requirements

  • Bachelor's degree plus 2 years related experience
  • Experience with eTMF systems and vendors
  • Working knowledge of FDA and ICH/GCP guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter