Associate II, TMF Operations

Accountabilities: Review and approve essential Trial Master File (TMF) documents in accordance with applicable standard operating procedures (SOPs), work instructions, and established quality standards. Process, review, and resolve rejected TMF documents across complex clinical studies and sponsor portfolios, working with both electronic and hard-copy records. Conduct periodic TMF quality control reviews to verify compliance with regulatory requirements, International Council for Harmonisation Good Clinical Practice (ICH GCP), sponsor expectations, and industry best practices. Prepare TMF quality control checklists for project team review and maintain associated study documentation, trackers, and records. Use electronic document management repositories and eTMF systems to review, classify, index, process, and maintain essential clinical trial documentation accurately. Ensure document management activities follow applicable SOPs, ALCOA principles, country-specific regulations, and established document handling practices. Identify trends, recurring issues, and documentation quality concerns, communicating findings to the relevant Records Management and Compliance (RMC) Lead and escalating issues when necessary. Support the RMC Lead with study-related SharePoint documentation, administrative tasks, and deputy coverage as required. Verify document naming conventions, cross-checks, and dependencies within the eTMF to support consistency, traceability, and completeness. Collaborate with global project team members to resolve documentation discrepancies and maintain high standards throughout the clinical trial document lifecycle. Requirements A university degree is preferred, ideally in Life Sciences, together with approximately 1–2 years of relevant professional experience. Proficiency in English, with strong written and verbal communication skills. Experience using an electronic document repository or eTMF system, including document recognition, data collection, indexing, review, and editing. A general understanding of clinical research principles and processes; experience in a highly regulated industry is an advantage. Knowledge of essential clinical trial documentation, document management practices, and quality control procedures is beneficial. Ability to understand document cross-checks and dependencies within an eTMF and consistently follow standardized document naming conventions. Strong attention to detail and a commitment to maintaining accurate, complete, and compliant records. Excellent planning and organizational skills, with the ability to manage multiple detailed tasks and meet deadlines in a changing work environment. Sound judgment and the ability to work independently under general direction while recognizing when guidance or escalation is needed. Proficiency in Microsoft Word and Excel, with the ability to follow applicable SOPs and sponsor-specific procedures. A collaborative approach and the ability to communicate effectively with project teams and colleagues across different locations and time zones. Flexibility and adaptability when responding to changing study priorities and documentation requirements. Benefits Remote work arrangement for eligible candidates based in Brazil. Full-time employment opportunity. No travel required. Opportunity to develop expertise in clinical trial documentation, TMF operations, and eTMF systems. Exposure to international clinical research projects and collaboration with global teams. Opportunities to strengthen knowledge of ICH GCP, regulatory compliance, document quality control, and clinical research standards. Experience working in a structured, quality-focused environment supporting clinical research and the development of new therapies.