Associate II, TMF Operations – Europe/LATAM

🔥 1 minute ago

🌐 United Kingdom, Spain, +7 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇨🇿 Czechia – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote 🇧🇬 Bulgaria – Remote 🇷🇸 Serbia – Remote 🇬🇪 Georgia – Remote 🇭🇷 Croatia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🚫👨‍🎓 No degree required

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 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

• Review and approve essential TMF documents in line with relevant SOPs and working practices. • Process, review, and resolve rejected TMF documents across complex studies or sponsor portfolios in electronic and hard-copy formats. • Perform periodic TMF Quality Control reviews to support compliance with regulatory requirements, ICH GCP, sponsor expectations, and industry best practices. • Prepare TMF Quality Control checklists for Project Team review and maintain associated study documentation and trackers. • Use electronic document management and eTMF systems to review, classify, and process essential documents accurately. • Identify and communicate TMF trends, issues, and quality concerns to the RMC Lead, escalating issues promptly when required. • Support the RMC Lead with study SharePoint documentation and other administrative activities, and provide deputy coverage when required. • Maintain essential documents in accordance with applicable SOPs, ALCOA principles, country regulations, and established document management practices. • Collaborate with Worldwide Project Team members across the globe, working with RMC Leads and internal teams to identify TMF trends, resolve issues, and maintain high standards throughout the document lifecycle.

🎯 Requirements

• A university degree is preferred, ideally in Life Sciences, combined with up to 1–2 years of relevant experience. • Proficiency in English, with strong written and verbal communication skills. • Experience using an electronic document repository or eTMF, together with strong document recognition, data collection, indexing, and editing skills. • General understanding of clinical research principles and processes; knowledge of working within a highly regulated industry is desirable. • Strong attention to detail, with the ability to manage multiple detailed tasks accurately in a deadline-oriented and rapidly changing environment. • Strong planning and organizational skills, sound judgment, and the ability to work effectively under general direction while seeking support when needed. • Ability to understand document cross-checks and dependencies within an eTMF and follow standardized document naming conventions. • Proficiency in Microsoft Word and Excel, with the ability to understand and follow applicable Worldwide and sponsor standard operating procedures.