Trial Master File Associate

Jobtailor; California (MO); On-site; USD 85,000 - 120,000; Full time

Job summary

Jobtailor is seeking a skilled TMF specialist to manage Trial Master Files in regulated clinical environments. You will maintain eTMF documents, perform quality control reviews, and ensure inspection-ready filing.

Collaborate with Clinical Operations, CROs, and vendors to align on document flow and TMF expectations. You will monitor TMF health metrics, drive timely resolutions, and support audits, FDA inspections, and regulatory inquiries.

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or related field or equivalent.
• 2–4+ years of TMF management or clinical document management experience in biotech/pharma/CRO.
• Experience maintaining electronic TMF (eTMF) in regulated clinical trials.
• Hands-on experience with Veeva Vault eTMF or similar platforms.
• Familiarity with ICH-GCP, 21 CFR Part 11, CDISC TMF, and FDA/global regulations.

Responsibilities

• Maintain assigned study TMFs, ensuring filing accuracy and contemporaneous documentation per TMF standards.
• Perform routine QC reviews to identify missing, incomplete, or misfiled documents and drive timely resolution.
• Monitor TMF health, completeness, and timeliness; communicate risks and trends to stakeholders.
• Partner with Clinical Operations, CROs, vendors on document flow and TMF filing expectations.
• Support TMF transfers, reconciliation, and vendor/CRO reconciliation activities.
• Assist audits/regulatory inspections by maintaining inspection-ready documentation.
• Track and resolve TMF queries, issues, and corrective actions.
• Support TMF plans, SOPs, work instructions, and related documentation.
• Assist with user training and adoption of eTMF systems and processes.

Skills

TMF Management

ETMF Systems

Veeva Vault eTMF

TMF Quality Control

CDISC TMF Standard Model

21 CFR Part 11 Compliance

Education

Bachelor's degree in Life Sciences or related field

Tools

Veeva Vault eTMF

Trial Interactive

CTMS Platforms

Job description

• 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
• Monitor TMF health, completeness, and timeliness metrics; communicate risks, trends, and outstanding issues
• Partner with Clinical Operations, CROs, vendors, and cross-functional teams on document flow and TMF filing expectations
• Support vendor and CRO reconciliation activities and TMF transfer processes
• Assist with audits and regulatory inspections by maintaining complete, accessible, inspection-ready documentation
• Track, reconcile, and help resolve TMF queries, issues, and corrective actions
• Support TMF plans, filing guidance, work instructions, SOPs, and related documentation
• Assist with user support, training, and adoption of eTMF processes and systems
• Contribute to TMF process improvements and quality initiatives
• 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
• Experience supporting FDA BIMO regulatory inspections preferred
• Experience supporting global clinical studies across multiple phases and working directly with CROs and external vendors preferred
• Familiarity with CTMS platforms and TMF-related inspection preparation activities preferred
• Experience supporting SOP development, TMF training, or process improvement initiatives preferred

Core Competencies

Demonstrates expertise in Trial Master File (TMF) management, ensuring compliance with ICH-GCP guidelines and regulatory requirements while maintaining inspection-ready documentation. Proficient in electronic TMF systems and quality control processes to support clinical operations and continuous improvement initiatives.

Highest-signal resume keywords

• TMF Management
• ETMF Systems
• ICH-GCP Guidelines
• Veeva Vault eTMF
• TMF Quality Control

Hard Skills

• TMF Management
• Clinical Document Management
• Quality Control Reviews
• TMF Health Metrics Analysis
• SOP Development
• Inspection Readiness Support
• Reconciliation Activities
• TMF Process Improvement
• CDISC TMF Standard Model
• 21 CFR Part 11 Compliance

Soft Skills

• Commitment to Quality
• Attention to Detail
• Problem-Solving
• Collaboration
• Communication

Industry Keywords

• Clinical Operations
• Biotechnology
• Pharmaceutical
• CRO
• FDA BIMO Inspections

Tools & Technologies

• Veeva Vault eTMF
• Trial Interactive
• CTMS Platforms