TMF Quality Specialist (Contract)

Experience

• 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 the CDISC Reference Model, TMF structure, ICH/GCP, Good Documentation Practice, and regulatory documentation requirements.
• Experience partnering with or overseeing CROs performing TMF activities.
• Hands-on involvement in system reporting, dashboard development, or configuration testing within Veeva Vault.
• Exposure to multiple phases of clinical trial conduct (startup through close-out and TMF archiving).
• Familiarity with additional Veeva products such as CTMS or Vault RIM.

• Proficiency in Microsoft Office Suite for collaboration with team members.
• Especially proficient in Excel for tracking, sorting, filtering, and managing large sets of metadata.
• Interpersonal skills, including conflict resolution in a fast-paced, deadline-driven environment.
• Strong attention to detail and organizational skills including the ability and drive to follow through on detailed tasks to closure.
• Analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

• Perform detailed QC reviews of TMF documents to verify metadata accuracy, confirm proper filing, and ensure 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 help ensure quality, timeliness, and completeness.
• Assist with audit and inspection preparation by supporting the TMF team in documentation readiness activities.

• Contribute to the continuous improvement of Oversight Review processes within Veeva Vault eTMF, including workflows, dashboards, and metrics.
• Support the development of review standards, success metrics, and monitoring tools that provide visibility into TMF quality, completeness, and inspection readiness.
• Support TMF Operations leadership in identifying process improvement opportunities and contributing to the 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 the 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.