eTMF Specialist

As an eTMF Specialist , your role is integral to managing and optimizing the electronic Trial Master File (eTMF) to ensure global clinical trials run seamlessly.

Key areas of responsibilities:

Managing centralized clinical documentation activities for global trials. Uploading and conducting rigorous quality reviews of eTMF documents for inspection readiness. Ensuring compliance with ALCOA Plus principles in documentation. Collaborating with study teams to maintain high document quality, timeliness, and completeness. Acting as the primary point of contact for document management activities. Supporting clinical trials from initiation to close-out phases. Providing feedback on quality issues and proactively resolving documentation gaps. Qualifications To qualify for the eTMF Specialist position, candidates must meet the following criteria: A bachelor's degree in Life Sciences, Business Administration, or equivalent experience. An advanced degree is a plus. 1-2 years of experience in clinical trial documentation management or a related field. Comprehensive knowledge of ICH/GCP guidelines and the drug development process. Familiarity with Clinical Trial Master File Systems, with Veeva Vault preferred experience. Proficiency in MS Office Suite, SharePoint, and clinical trial-enabling technologies. Skills Required Strong organizational and time-management skills. Analytical and decision-making abilities to evaluate and prioritize tasks. Exceptional written and oral communication skills. Ability to work independently and manage multiple priorities. Adaptability and resilience in a dynamic environment. Demonstrated ability to collaborate and influence within a matrix structure. High attention to detail for maintaining quality and compliance in clinical documentation.