TMF Quality Specialist (Contract)

Jobgether

2d • Remote

About The Position

This role offers a unique opportunity to contribute directly to the quality, compliance, and inspection readiness of clinical trial documentation. You will play a critical role in ensuring that Trial Master Files meet the highest regulatory and quality standards across the full study lifecycle. Working closely with cross-functional teams, you will support quality control, process improvement, and system enhancements within a highly regulated environment. This position blends hands-on TMF review with strategic oversight and continuous improvement initiatives. You will operate in a collaborative, fast-paced biotech setting where precision, accountability, and regulatory excellence are essential. Your work will help strengthen operational rigor, audit readiness, and overall clinical trial quality.

Requirements

• Minimum of 5 years of experience in TMF Operations, including extensive hands-on work with Veeva Vault eTMF.
• At least 2 years of direct TMF QC review experience, with strong knowledge of clinical documentation standards and metadata.
• Solid understanding of ICH GCP, CDISC Reference Model, TMF structure, Good Documentation Practice, and regulatory requirements.
• Experience supporting TMF planning, system setup, enhancements, and oversight processes.
• Strong analytical, organizational, and attention-to-detail skills, with a proven ability to manage complex documentation tasks.
• High proficiency in Microsoft Office, particularly Excel for managing large data and metadata sets.
• Excellent communication and interpersonal skills, with the ability to collaborate in fast-paced, deadline-driven environments.

Nice To Haves

• Experience working with CROs, system dashboards, reporting tools, and additional Veeva platforms is a plus.

Responsibilities

• Perform detailed quality control reviews of TMF documents to ensure accuracy, completeness, and compliance with ICH GCP, regulatory standards, and internal SOPs.
• Identify documentation gaps, inconsistencies, and quality risks, collaborating closely with TMF Operations to drive timely resolution.
• Support continuous TMF review activities across all clinical trial phases to ensure ongoing inspection readiness.
• Contribute to audit and regulatory inspection preparation through documentation review and remediation support.
• Help design, improve, and maintain Oversight Review processes, workflows, dashboards, and metrics within Veeva Vault eTMF.
• Assist in business process ownership activities for system enhancements, including requirements gathering, testing, validation, and change management.
• Support training development, user guidance, and cross-functional communication related to TMF systems and processes.

Benefits

• Competitive hourly rate of $60.00.
• Fully remote-friendly contract environment with flexible working arrangements.
• Exposure to late-stage clinical development programs and regulatory-focused initiatives.
• Opportunity to work within a highly collaborative, cross-functional biotech setting.
• Valuable hands-on experience in inspection readiness, TMF oversight, and system optimization.

What This Job Offers

• Career Level: Mid Level
• Education Level: No Education Listed