Trial Master File (TMF) Associate
Job Description
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About Oruka Therapeutics
Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Their mission is to offer patients suffering from conditions like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies engineered by Paragon Therapeutics, targeting core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases.
The Role
We 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 serves as a key partner to Clinical Operations, CROs, vendors, and study teams, ensuring TMF records are complete, accurate, contemporaneous, and maintained in accordance with ICH-GCP guidelines, regulatory requirements, and company procedures.
This role contributes to TMF oversight activities, quality reviews, reconciliation efforts, health metric reporting, and continuous process improvement initiatives to support an inspection-ready TMF environment.
Key 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.
Requirements
- A Bachelor’s degree in Life Sciences, Health Sciences, or a related field, or equivalent experience.
- 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.
Preferred Requirements
- 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.
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Oruka Therapeutics
View Company ProfileOruka Therapeutics (operating at orukatx.com) is a biopharmaceutical company pioneering novel biologics to redefine treatment standards for chronic skin diseases. Founded by seasoned biopharma professionals and drug developers, the company is headquartered in Baltimore, Maryland, though its clinical operations span North America. Unlike conventional therapies that often fall short in addressing plaque psoriasis and psoriatic arthritis, Oruka’s approach focuses on developing targeted biologics designed to restore skin health and improve patient quality of life. Their pipeline centers on ORKA-002, a first-in-class therapeutic undergoing clinical trials to demonstrate efficacy in dose-ranging studies. This precision-driven methodology empowers dermatologists and rheumatologists to offer more effective, personalized care to patients suffering from debilitating conditions. Backed by substantial private financing, including an $180 million PIPE round led by Viking Global Investors and participation from Affinity, Oruka is poised to accelerate its clinical development with additional funding from a proposed $500 million underwritten offering.
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