TMF Reviewer I – Clinical Trial Master File Specialist
Location: Bangalore, India
Job Type: Full-Time
Category: Clinical Operations / Clinical Documentation
Experience Required: 4 to 8 years
Job Overview
The TMF Reviewer I is responsible for managing and reviewing electronic Trial Master Files (eTMF) to ensure completeness, accuracy, and regulatory compliance across clinical studies. This role plays a critical part in maintaining audit-ready documentation, supporting sponsor requirements, and ensuring adherence to global regulatory standards including ICH-GCP guidelines. The position involves close collaboration with cross-functional study teams to drive quality, consistency, and operational excellence in clinical documentation processes.
Key Responsibilities
Manage and review Trial, Country, and Site-level documentation within the electronic Trial Master File (eTMF) in alignment with sponsor and internal SOPs. Perform comprehensive TMF reviews, including document classification, indexing, and quality control checks to ensure compliance with regulatory and study-specific requirements. Conduct visual quality checks of electronic documents to ensure clarity, completeness, and readability prior to final submission. Maintain TMF in a continuous state of audit readiness by performing audit-ready checks and ensuring all documents meet regulatory expectations. Map sponsor TMF index with internal universal content validation (UCV) standards and perform quality control activities within sponsor systems where applicable. Track and manage essential study documents throughout the clinical trial lifecycle, ensuring timely collection and accurate filing. Identify, escalate, and resolve operational issues related to TMF management and documentation gaps. Prepare documentation for internal and external audits, support audit processes, and implement corrective and preventive actions based on audit findings. Collaborate with study teams, quality control units, and stakeholders to ensure seamless document management and compliance. Participate in internal and client audits, study meetings, and continuous improvement initiatives to enhance quality and productivity. Support training and mentoring activities for team members as required.
Education and Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, or a related discipline is required. A Master’s degree in Life Sciences or Business Administration is preferred. Equivalent clinical research experience may be considered in lieu of formal education.
Experience Requirements
A minimum of 4 to 8 years of experience in clinical research or TMF management is required. Candidates should have a strong understanding of Trial Master File processes, regulatory documentation requirements, and global compliance standards including ICH-GCP guidelines. Experience with electronic TMF systems and clinical documentation platforms is highly desirable.
Key Skills and Competencies
Strong knowledge of clinical trial documentation, regulatory requirements, and audit processes. Proficiency in eTMF systems, Microsoft Office tools, and document management software such as Adobe Acrobat. Excellent attention to detail with the ability to ensure high-quality and compliant documentation. Strong analytical and problem-solving skills to identify and resolve documentation gaps. Effective communication and interpersonal skills for cross-functional collaboration. Ability to manage multiple studies and priorities in a fast-paced clinical research environment. Commitment to continuous improvement and maintaining audit readiness at all times.
Work Environment
This role is primarily office-based with minimal travel requirements, typically less than 10 percent, for sponsor meetings or client interactions when required.
Why Join This Role
This position offers an opportunity to work at the core of clinical research documentation, ensuring compliance and quality in global clinical trials. It provides exposure to advanced eTMF systems, regulatory processes, and cross-functional collaboration in a dynamic and growth-oriented environment.
Uttar Pradesh :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Sheffield |Oxfordshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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