Precision for Medicine

QualityReviewSpecialist

₹7–10L ~AI est. Bengaluru, Karnataka, India
The Brief

“Quality Review Specialist at Precision for Medicine. Skills: TMF Quality Reviews, eTMF systems. Perform periodic TMF Quality Reviews. Generate TMF documentation”

Industry & Context.

Problems you'll solve

Identify issues

What They're Looking For.

Must Have

Bachelor’s degree or international equivalent, 2 years of related experience, Microsoft Office package fluency, eTMF systems and vendors experience, Working knowledge of FDA & ICH/GCP regulations

What You'll Do.

Perform periodic TMF Quality Reviews

Generate TMF documentation

File TMF documentation

Inform TMF Lead of TMF status

Monitor document processing issues

Escalate document processing issues

Support updates to expected documents

Open placeholders in TMF

Identify potential training needs

Identify studies at serious risk

Escalate studies at serious risk

How You'll Work.

Communication Scope

Verbal communication; Written communication

Free ATS check

Applying for this Quality Review Specialist role?

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