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Quality Review Specialist

Precision Medicine Group

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, audit-ready, and maintained in compliance with regulatory standards.
• Day-to-day responsibilities include conducting timely and high-quality TMF reviews, generating and filing review documentation, identifying missing or incorrect documents, and informing the TMF Lead of updates needed regarding sites, contacts, and country-specific requirements.
• The role supports the identification of training needs, monitors document processing issues, and escalates concerns about non-response or inconsistencies from Functional Leads to the TMF Lead with managerial support.
• The specialist contributes to maintaining audit readiness by updating expected documents, opening placeholders where needed, and identifying studies at serious risk due to poor quality, all while working under the guidance of a Manager and adhering to SOPs and ICH-GCP guidelines.
• This role is critical for ensuring the integrity of clinical trial documentation within Precision Medicine Group’s portfolio, particularly for less complex or smaller studies, and offers exposure to global TMF operations in a remote work environment.

🎯 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
• Strong interpersonal skills, organizational abilities, and time management to meet deadlines
• Ability to identify issues and escalate appropriately and effectively

🏖️ Benefits

• Remote work opportunity based in India
• Opportunity to gain hands-on experience with eTMF systems and global clinical trial documentation
• Exposure to FDA and ICH/GCP regulatory standards in a professional setting
• Supportive environment with managerial guidance for issue escalation and skill development
• Contribution to audit-ready trial master files, enhancing compliance and quality in clinical research

Skills & Technologies

GCP

Remote

Degree Required

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Precision Medicine Group

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About Precision Medicine Group

Precision Medicine Group (PMG) is a leading life sciences consulting firm dedicated to accelerating the development and commercialization of precision medicine. They offer a comprehensive suite of services, including strategy, market access, regulatory affairs, and commercialization support. PMG partners with pharmaceutical, biotechnology, and diagnostic companies to navigate the complex landscape of personalized healthcare. Their expertise spans various therapeutic areas and advanced molecular technologies. By leveraging deep scientific knowledge and market insights, PMG helps clients optimize their drug development pipelines, secure regulatory approvals, and successfully launch innovative therapies. They are committed to advancing patient care through the power of precision medicine, ensuring that the right treatments reach the right patients at the right time.

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