Associate II, TMF Operations (LATAM)

Help maintain the quality and integrity of clinical research by ensuring essential Trial Master File documents are accurate, complete, and managed in line with regulatory and industry standards. You will take ownership of document processing, review, and quality control activities across complex studies or sponsor portfolios. Your attention to detail will support inspection-ready TMFs and help project teams deliver research that makes a meaningful impact on patients' lives. As part of a globally focused team, you will collaborate with Worldwide project teams and work with a range of electronic document management and eTMF systems. This is a remote role open to candidates based in Latin America. You will collaborate with global teams across multiple time zones.

Responsibilities

Perform TMF Approver and TMF Quality Control Reviewer activities in accordance with relevant procedures and working practices; Process, review, and resolve rejected TMF documents for complex studies or sponsor portfolios; Manage essential documents in electronic and hard-copy formats; Prepare periodic TMF Quality Control checklists for project team review; Conduct regular quality checks to support compliance with regulatory requirements, ICH GCP, sponsor expectations, and industry best practices; Review, classify, index, and process essential documents using electronic document management and eTMF systems; Apply consistent document naming and filing standards to maintain accurate, high-quality trial records; Collaborate with global project teams to address documentation issues and support TMF quality

Requirements

Proficiency in English, with excellent written and verbal communication skills; Up to one to two years of relevant TMF experience within the CRO or pharmaceutical industry; Experience in data collection, document indexing, editing, and standardized document naming; Strong attention to detail, with the ability to manage multiple tasks accurately and meet deadlines; Effective planning, organizational, and interpersonal skills in a fast-paced, changing environment; Proficiency in Microsoft Word and Excel; Familiarity with electronic document repositories or eTMF systems, together with a general understanding of clinical research principles and processes

Nice to have

A university degree, ideally in a life science discipline