TMF Operations Associate II — Europe (Remote)

Worldwide Clinical Trials Limited; United States; Remote; GBP 32,000 - 42,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to join the global TMF team. You will review and process TMF documents, conduct quality control, and ensure ALCOA-compliant records across complex studies.

This remote EU role collaborates with global teams and RMC Leads, maintaining thorough documentation and trackers to support regulatory expectations. The role emphasizes attention to detail, strong communication, and proficiency with eTMF systems, Word, and Excel, with

Qualifications

• A university degree is preferred, ideally in 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; highly regulated industry experience is desirable.
• Strong attention to detail, with the ability to manage multiple tasks accurately under deadlines.
• Strong planning and organizational skills, sound judgment, and ability to work under general direction.
• Ability to understand document cross-checks and dependencies within an eTMF and follow standard naming conventions.
• Proficiency in Microsoft Word and Excel, and ability to follow SOPs.

Responsibilities

• Review and approve essential TMF documents in line with SOPs and practices.
• Process, review, and resolve rejected TMF documents across studies or sponsor portfolios.
• Perform periodic TMF Quality Control reviews to ensure regulatory compliance.
• Prepare TMF Quality Control checklists for Project Team review and maintain study documentation and trackers.
• Use electronic document management and eTMF systems to review, classify, and process documents.
• Identify TMF trends and quality concerns and communicate them to the RMC Lead.
• Support study documentation and provide deputy coverage as needed.
• Maintain documents in line with SOPs, ALCOA principles, and country regulations.

Skills

Attention to detail

English proficiency

MS Word & Excel

eTMF experience

Document management

Education

Life Sciences degree

1–2 years relevant experience

Tools

eTMF systems

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to join the global TMF team. You will review and process TMF documents, conduct quality control, and ensure ALCOA-compliant records across complex studies.

This remote EU role collaborates with global teams and RMC Leads, maintaining thorough documentation and trackers to support regulatory expectations. The role emphasizes attention to detail, strong communication, and proficiency with eTMF systems, Word, and Excel, with