Trial Master File (TMF) Associate

Job Title:     Trial Master File (TMF) Associate

Location:     Remote or Hybrid 3 days/week if located near office in Waltham, 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.
• 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.

Compensation:

An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity. The anticipated salary range for Associate level is $104,000 - $125,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states. 

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.