TMF Operations Associate II - Remote, Global Impact

Worldwide Clinical Trials; United States; Remote; MXN 979,000 - 1,431,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure essential TMF documents are accurate, complete, and compliant. You will review, process, and quality-check TMF files across studies and sponsor portfolios, applying ALCOA principles and ICH GCP standards.

You will work with global teams, identify TMF trends, resolve issues, and maintain study documentation throughout the lifecycle, with minimal travel and strong collaboration.

Qualifications

• University degree preferred, Life Sciences, 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, 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.

Responsibilities

• 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.

Skills

Attention to detail

Communication skills

English proficiency

Planning & organizing

Education

Bachelor's degree Life Sciences

Tools

eTMF system

Microsoft Word

Microsoft Excel

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to ensure essential TMF documents are accurate, complete, and compliant. You will review, process, and quality-check TMF files across studies and sponsor portfolios, applying ALCOA principles and ICH GCP standards.

You will work with global teams, identify TMF trends, resolve issues, and maintain study documentation throughout the lifecycle, with minimal travel and strong collaboration.