Quality Review Specialist

PFM Asset Management

Job Overview

Location

Remote, India

Job Type

Full-time

Full Job Description

📋 Description

• The Quality Review Specialist performs periodic TMF Quality Reviews for assigned projects to ensure study Trial Master Files are complete, accurate, and audit-ready, supporting compliance with regulatory standards.
• Day-to-day responsibilities include conducting timely and high-quality reviews, generating and filing TMF documentation, identifying missing or incorrect documents, and escalating issues to the TMF Lead when Functional Leads fail to respond or update records.
• The role supports updates to expected documents, opens placeholders in the TMF as needed, and identifies potential training needs to improve team-wide consistency and quality in TMF maintenance.
• Working under the guidance of a Manager, the specialist monitors study quality, escalates high-risk studies due to poor TMF quality, and contributes to maintaining audit readiness across the Precision portfolio.
• The position is part of a specialized team focused on clinical trial documentation integrity, requiring collaboration with Functional Leads and TMF leadership to uphold regulatory compliance and operational excellence.
• The specialist gains hands-on experience with eTMF systems, FDA and ICH/GCP guidelines, and internal SOPs, developing expertise in clinical trial documentation management and quality assurance processes.
• This role offers the opportunity to build strong organizational, communication, and problem-solving skills while contributing to the integrity of clinical research in a remote, India-based setting.

🎯 Requirements

• Bachelor’s degree (or international equivalent) + 2 years of related experience
• Established experience and fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Experience with eTMF systems and vendors
• Working knowledge of FDA and ICH/GCP regulations and guidelines
• Demonstrated interpersonal skills, organizational abilities, and time management to meet deadlines
• Ability to identify issues and escalate appropriately and effectively

🏖️ Benefits

• Remote work flexibility based in India
• Opportunity to gain expertise in clinical trial documentation and regulatory compliance
• Professional development through exposure to FDA, ICH/GCP, and internal SOPs
• Collaboration with cross-functional teams in a specialized TMF environment
• Contribution to audit-ready Trial Master Files and clinical research integrity
• Supportive management structure with clear escalation paths and guidance

Skills & Technologies

GCP

Remote

Degree Required

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PFM Asset Management

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About PFM Asset Management

PFM Asset Management is a distinguished investment management firm specializing in providing tailored investment solutions for institutional clients. With a strong focus on fiduciary responsibility and long-term value creation, PFM offers a comprehensive range of services including fixed income, equity, and alternative investment strategies. Their approach is grounded in rigorous research, disciplined risk management, and a deep understanding of client objectives. PFM is committed to transparency and client service, striving to be a trusted partner in helping institutions achieve their financial goals. They serve a diverse clientele, including public funds, corporate pensions, endowments, and foundations, adapting their strategies to meet unique needs.

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