TMF Quality & Compliance Associate - Remote

Oruka Therapeutics; Menlo Park, Waltham (CA, MA); Hybrid; USD 104,000 - 125,000; Full time

Benefits offered by this job

Startup culture

Competitive compensation

Inclusive team environment

Growth opportunities

Job summary

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.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–4+ years TMF management/clinical documentation experience in biotech/pharma/CRO.
• Knowledge of CDISC TMF Standard Model, ICH-GCP R(3), 21 CFR Part 11, FDA requirements.
• Experience with eTMF systems (Veeva Vault, Trial Interactive).
• TMF quality control, reconciliation, and inspection readiness experience.

Responsibilities

• Maintain study TMFs, file documents per TMF standards and procedures.
• Conduct quality checks and drive timely resolution of issues.
• Monitor TMF health metrics and communicate risks to stakeholders.
• Collaborate with Clinical Operations, CROs, vendors and study teams for consistent document flow.
• Assist with TMF transfer, audits, inspections, and training on eTMF processes.
• Support TMF plans, SOPs, and process improvements.

Skills

TMF management

ICH-GCP

FDA compliance

Quality control

Metrics analysis

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

Veeva Vault eTMF

Trial Interactive

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.