TMF Associate (Remote) – Quality & Compliance

Oruka Therapeutics Inc; Menlo Park (CA); Remote; USD 104,000 - 125,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Growth opportunities

Job summary

Oruka Therapeutics Inc. is seeking a highly organized Trial Master File (TMF) Associate. This remote/hybrid role supports TMF management throughout the study lifecycle, ensuring documentation is complete, compliant, and inspection-ready.

You will partner with Clinical Operations, CROs, and vendors to maintain TMF health and drive quality improvements. Responsibilities include quality control, reconciliation, and audits preparation, with exposure to ICH-GCP, CDISC TMF, and FDA regulations.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2-4+ years of TMF management experience in biotech/pharma/CRO environments.
• Experience with CDISC TMF Standard Model, ICH-GCP, 21 CFR Part 11, FDA/global regulations.

Responsibilities

• Maintain assigned study TMFs per TMF standards and procedures.
• Perform routine quality control reviews to identify gaps and resolve with teams.
• Monitor TMF health metrics and communicate risks to stakeholders.
• Collaborate with Clinical Operations, CROs, vendors to ensure proper document flow.

Skills

TMF management

eTMF (Veeva Vault)

QA/compliance

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault eTMF

Trial Interactive

Job description

Oruka Therapeutics Inc. is seeking a highly organized Trial Master File (TMF) Associate. This remote/hybrid role supports TMF management throughout the study lifecycle, ensuring documentation is complete, compliant, and inspection-ready.

You will partner with Clinical Operations, CROs, and vendors to maintain TMF health and drive quality improvements. Responsibilities include quality control, reconciliation, and audits preparation, with exposure to ICH-GCP, CDISC TMF, and FDA regulations.