Job at a glance
About Us: Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases 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 that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.
Job Title: Trial Master File (TMF) Associate Location: Remote or Hybrid 3 days/week if located near office in W altham, MA or Menlo Park, CA will be required. Job Summary 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.
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: 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. Ex