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Oruka Therapeutics

TMF Quality & Compliance Associate - Remote

waltham, MA

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About this opportunity

Oruka Therapeutics lists this TMF Quality & Compliance Associate - Remote opportunity in waltham, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Oruka Therapeutics seeks a highly organized Trial Master File (TMF) Associate to manage TMF documentation, ensure inspection readiness, and drive quality across clinical studies. This role partners with Clinical Operations, CROs, vendors, and study teams to maintain complete, accurate TMF records in line with ICH-GCP and FDA requirements.

The position offers remote work with a hybrid option for candidates near the Waltham, MA or Menlo Park, CA offices.

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