Remote TMF Operations Associate II - LATAM

Worldwide Clinical Trials; United States; Remote; MXN 240,000 - 420,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure Trial Master File documents are accurate, complete, and inspection-ready across complex studies. You will manage TMF documentation in electronic and hard-copy formats and support quality control activities.

This remote role is open to candidates based in Latin America. You will collaborate with global teams across time zones and contribute to regulatory compliance, ICH GCP standards, and industry best practices while

Qualifications

• University degree preferred, life sciences.
• Up to 1–2 years TMF experience within CRO/pharma.
• Proficiency in English, with excellent written and verbal communication.
• Experience in data collection, document indexing, editing, and standardized document naming.
• Strong attention to detail, with ability to manage multiple tasks and meet deadlines.
• Effective planning, organizational, and interpersonal skills in a fast-paced environment.
• Proficiency in Microsoft Word and Excel.
• Familiarity with electronic document repositories or eTMF systems.

Responsibilities

• Perform TMF Approver and TMF Quality Control Reviewer activities per procedures.
• Process, review, and resolve rejected TMF documents for complex studies.
• 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 regulatory compliance, ICH GCP, sponsor expectations.
• Review, classify, index, and process essential documents using eTMF systems.
• Apply consistent document naming and filing standards to maintain high-quality records.
• Collaborate with global project teams to address documentation issues and support TMF quality.

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure Trial Master File documents are accurate, complete, and inspection-ready across complex studies. You will manage TMF documentation in electronic and hard-copy formats and support quality control activities.

This remote role is open to candidates based in Latin America. You will collaborate with global teams across time zones and contribute to regulatory compliance, ICH GCP standards, and industry best practices while