Associate II – TMF Operations

🕒 August 11

🌐 Argentina, Mexico, +1 more countries – Remote

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

⏰ Full Time

🟢 Junior

🟡 Mid-level

⚙️ Operations

🚫👨‍🎓 No degree required

👻 Ghost score 28%

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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

• Fulfil the “TMF Approver” and/or “TMF QC Reviewer” roles according to relevant SOPs and working practices • Process, review, and resolve rejected Trial Master File documents for complex studies or Sponsor portfolios in electronic and hard copy formats • Prepare periodic TMF Quality Control checklists for Project Team review • Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices • Use Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents • Collaborate regularly with members of the Worldwide Project Team

🎯 Requirements

• Data collection, indexing, and editing skills • Ability to adhere to standardized document naming conventions • Excellent written and verbal communication skills • Strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment • Ability to handle multiple, highly detailed tasks with exceptional accuracy • Strong planning and organizational skills • Proficiency in Microsoft Word and Excel • Ability to develop proficiency in an electronic document repository or eTMF • General understanding of clinical research principles and processes • University Degree preferred; Life Science desirable • Up to 1–2 years of relevant TMF experience within the CRO/Pharma industry

🏖️ Benefits

• Supportive and cohesive teams • Diverse and inclusive work environment • Equal employment opportunities • Exceptional employee experiences • Opportunity to collaborate with global project teams

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