Associate II, TMF Operations – LATAM

🔥 0 minutes ago

🌐 Argentina, Mexico, +1 more countries – Remote

🇦🇷 Argentina – Remote 🇲🇽 Mexico – Remote 🇧🇷 Brazil – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🚫👨‍🎓 No degree required

👻 Ghost score 10%

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• 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

• A university degree is preferred, ideally in a life science discipline. • Up to one to two years of relevant TMF experience within the CRO or pharmaceutical industry. • Proficiency in English, with excellent written and verbal communication skills. • 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.

🏖️ Benefits

• Equal employment opportunities • Diverse and inclusive work environment • Collaborative and supportive teams • Accessible leadership • Employee opportunities to succeed and thrive