TMF Operations Associate II (Remote)

Worldwide Clinical Trials; Valencia; Remote; EUR 42,000 - 62,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to join a global TMF team. You will review, process, and quality-check TMF documents, ensuring completeness and regulatory compliance across complex studies and sponsor portfolios.

You will collaborate with global project teams, RMC leads, and internal groups to identify TMF trends, resolve issues, and maintain document lifecycle quality. Remote role for Europe-based candidates with no travel requirements.

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; 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 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 (ICH GCP, sponsor expectations).
• 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, issues, and quality concerns and escalate to the RMC Lead.
• Support the RMC Lead with study SharePoint documentation and administrative activities.
• Maintain essential documents in accordance with SOPs, ALCOA principles, country regulations.

Skills

University degree

Life Sciences

1-2 years experience

English proficiency

Education

University degree

Tools

eTMF system

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations to join a global TMF team. You will review, process, and quality-check TMF documents, ensuring completeness and regulatory compliance across complex studies and sponsor portfolios.

You will collaborate with global project teams, RMC leads, and internal groups to identify TMF trends, resolve issues, and maintain document lifecycle quality. Remote role for Europe-based candidates with no travel requirements.