Remote TMF Operations Associate II (Europe/LATAM)

Worldwide; Valencia; Remote; EUR 42,000 - 66,000; Full time

Job summary

Worldwide Clinical Trials is seeking an Associate II, TMF Operations for a remote European-based role. You will review, process, and quality-check TMF documentation across complex studies, ensuring ALCOA principles and ICH GCP standards are met.

You will collaborate with global teams, prepare QC checklists, and maintain study documentation while supporting RMC Leads and SharePoint activities. English proficiency and attention to detail are essential.

Qualifications

• A university degree is preferred, ideally Life Sciences.
• Proficiency in English with strong written and verbal communication skills.
• Experience with electronic document repositories or eTMF and document data handling.
• Strong attention to detail and ability to manage multiple tasks to deadlines.
• Familiarity with regulatory frameworks (ICH-GCP) is beneficial.

Responsibilities

• Review and approve essential TMF documents in line with SOPs.
• Process, review, and resolve rejected TMF documents across studies.
• Perform periodic TMF Quality Control reviews for compliance.
• Prepare TMF Quality Control checklists for project teams.
• Use electronic document management and eTMF systems for document handling.
• Identify TMF trends and communicate issues to the RMC Lead.
• Support study SharePoint documentation and provide deputy coverage.
• Maintain documents according to SOPs and regulations.

Skills

Attention to detail

English proficiency

Document management

Planning & organization

eTMF knowledge

Education

University degree preferred

Tools

eTMF system

SharePoint

Microsoft Word

Microsoft Excel

Job description

Worldwide Clinical Trials is seeking an Associate II, TMF Operations for a remote European-based role. You will review, process, and quality-check TMF documentation across complex studies, ensuring ALCOA principles and ICH GCP standards are met.

You will collaborate with global teams, prepare QC checklists, and maintain study documentation while supporting RMC Leads and SharePoint activities. English proficiency and attention to detail are essential.