Trial Master File (TMF) Associate
About The Position
Oruka Therapeutics is developing novel biologics for chronic skin diseases. As they build their core team, they are seeking a highly organized and detail-oriented Trial Master File (TMF) Associate to support the management, quality, and inspection readiness of clinical trial documentation throughout the clinical study lifecycle. The TMF Associate will partner with Clinical Operations, CROs, vendors, and study teams to ensure TMF records are complete, accurate, contemporaneous, and maintained in accordance with ICH-GCP guidelines, regulatory requirements, and company procedures. This role involves TMF oversight, quality reviews, reconciliation, health metric reporting, and continuous process improvement to support an inspection-ready TMF environment.
Requirements
- Bachelor's degree in Life Sciences, Health Sciences, or related fields or equivalent.
- 2-4+ years of experience in TMF management, clinical document management, clinical operations, or clinical research within biotechnology, pharmaceutical, or CRO environments.
- Working knowledge of the CDISC TMF Standard Model, ICH-GCP R(3) guidelines, 21 CFR Part 11, and applicable FDA and global regulatory requirements.
- Experience maintaining electronic Trial Master Files (eTMF) in regulated clinical trial environments.
- Hands-on experience with Veeva Vault eTMF and/or Trial Interactive platforms required.
- Experience with TMF quality control, completeness reviews, reconciliation activities, and inspection readiness support.
- Ability to analyze TMF health metrics and identify risks, trends, and gaps requiring follow-up.
- Demonstrated commitment to quality, compliance, and continuous improvement.
Nice To Haves
- Experience supporting FDA BIMO regulatory inspections.
- Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors.
- Familiarity with CTMS platforms and TMF-related inspection preparation activities.
- Experience supporting SOP development, TMF training, or process improvement initiatives.
Responsibilities
- Maintain assigned study TMFs and ensure documents are filed accurately, contemporaneously, and according to TMF standards and company procedures.
- Perform routine quality control reviews to identify missing, incomplete, duplicate, or misfiled documents and drive timely resolution with study teams and functional areas.
- Monitor TMF health, completeness, and timeliness metrics; proactively communicate risks, trends, and outstanding issues to stakeholders.
- Partner with Clinical Operations, CROs, vendors, and cross-functional teams to ensure consistent document flow and adherence to TMF filing expectations.
- Support vendor and CRO reconciliation activities and assist with management of TMF transfer processes to ensure documentation completeness across all sources.
- Assist in preparing for audits and regulatory inspections by ensuring TMF documentation is complete, accessible, and inspection-ready.
- Track, reconcile, and help resolve TMF queries, issues, and corrective actions in collaboration with study teams and vendors.
- Support TMF plans, filing guidance, work instructions, SOPs, and other TMF-related documentation as needed.
- Assist with user support, training, and adoption of eTMF processes and systems.
- Contribute to TMF process improvements and quality initiatives that enhance compliance, efficiency, and inspection readiness.
- Maintain compliance with company SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
