TMF Quality Specialist (Contract) job opportunity at Jobgether.

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Jobgether TMF Quality Specialist (Contract)
Experience: 5 Years
Pattern: Remote
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degreeBachelor's (B.Sc.)
loacation United States Of America, United States Of America
loacation United States ..........United States Of America

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a TMF Quality Specialist (Contract) in United States.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.\nAccountabilities: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.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.Experience working with CROs, system dashboards, reporting tools, and additional Veeva platforms is a plus.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.\nWhy Apply Through Jobgether?We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.#LI-CL1

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