Remote TMF Operations Associate II – Europe

Worldwide Clinical Trials; United States; Remote; USD 58,000 - 67,000; Full time

Job summary

Worldwide Clinical Trials seeks an Associate II, TMF Operations for a remote role open to Europe-based candidates. You will review, process, and quality-check TMF documentation across studies, ensuring ALCOA-aligned records and regulatory compliance with ICH GCP standards.

You will collaborate with global teams, support RMC Leads, and maintain study documentation across multiple time zones with careful attention to quality and timelines.

Qualifications

• University degree preferred, ideally in Life Sciences.
• Proficiency in English with strong written and verbal communication skills.
• Experience using an electronic document repository or eTMF with indexing and editing skills.
• General understanding of clinical research principles and processes in a highly regulated industry.
• Strong attention to detail; ability to manage multiple tasks to deadlines.
• Strong planning and organizational skills; able to work with limited direction.
• Proficiency in Word and Excel; follow standard operating procedures.

Responsibilities

• Review and approve essential TMF documents per 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 regulatory compliance.
• Prepare TMF Quality Control checklists for Project Team review and tracking.
• Use electronic document management and eTMF systems to review, classify, and process documents.
• Identify TMF trends, issues, and quality concerns to the RMC Lead and escalate when needed.
• Support the RMC Lead with study SharePoint documentation and other administrative tasks; deputise when required.
• Maintain essential documents in accordance with SOPs, ALCOA principles, country regulations, and established practices.

Skills

English proficiency

Attention to detail

Documentation management

eTMF experience

Regulatory knowledge

Education

University degree in Life Sciences

Job description

Worldwide Clinical Trials seeks an Associate II, TMF Operations for a remote role open to Europe-based candidates. You will review, process, and quality-check TMF documentation across studies, ensuring ALCOA-aligned records and regulatory compliance with ICH GCP standards.

You will collaborate with global teams, support RMC Leads, and maintain study documentation across multiple time zones with careful attention to quality and timelines.