Tech Stack

Description

You will support the review, quality oversight, and maintenance of Trial Master File (TMF) documentation in accordance with GCP, ICH E6, regulatory requirements, and 4DMT SOPs. This includes QC review of TMF documents, developing oversight review processes in Veeva Vault eTMF, and representing the Business Process Owner perspective for system enhancements to ensure inspection readiness.

Requirements

• Minimum 5 years of relevant experience in TMF Operations including extensive hands-on work with Veeva Vault eTMF.
• At least 2 years performing TMF QC review, applying knowledge of clinical documentation content and metadata standards.
• Experience supporting TMF planning, implementation, and configuration activities including review of TMF Plans and participation in system setup or enhancements.
• Demonstrated understanding of CDISC Reference Model, TMF structure, ICH/GCP, Good Documentation Practice, and regulatory documentation requirements.
• Proficiency in Microsoft Office Suite, especially Excel for tracking, sorting, filtering, and managing large sets of metadata.
• Strong attention to detail and organizational skills including ability to follow through on detailed tasks to closure.
• Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.

Responsibilities

• Perform detailed QC reviews of TMF documents to verify metadata accuracy, proper filing, and compliance with ICH GCP, regulatory standards, and internal SOPs.
• Identify documentation gaps, inconsistencies, or quality issues and collaborate with TMF Operations team members to resolve them promptly.
• Support ongoing TMF review activities throughout the study lifecycle to ensure quality, timeliness, and completeness.
• Assist with audit and inspection preparation by supporting TMF team in documentation readiness activities.
• Contribute to continuous improvement of Oversight Review processes within Veeva Vault eTMF, including workflows, dashboards, and metrics.
• Support development of review standards, success metrics, and monitoring tools for TMF quality and inspection readiness.
• Identify process improvement opportunities and contribute to development of new tools, workflows, and best practices.
• Assist in preparing business requirements, documenting user needs, and participating in validation testing and user acceptance activities from BPO perspective.
• Provide input into change control documentation and support cross-functional collaboration with IT, Quality, and Managed Services teams during configuration updates.
• Help develop training materials, reference guides, and user communications to support adoption of new functionality or process changes.