Associate II – TMF Operations (Europe/LATAM) – Remote

About the role

We are seeking an Associate II to join our TMF Operations team, supporting Europe and LATAM studies on a fully remote basis. The role involves ensuring the quality and compliance of Trial Master Files across electronic and hard‑copy formats.

Key responsibilities

• Act as TMF Approver and/or TMF QC Reviewer according to SOPs.
• Process, review and resolve rejected TMF documents for complex or sponsor‑portfolio studies.
• Prepare and execute periodic TMF Quality Control checklists.
• Ensure adherence to regulatory, ICH GCP, sponsor and industry best practices.
• Utilise various Electronic Document Management and eTMF systems to classify and manage essential documents.

Required profile

• Strong data collection, indexing and editing abilities, following standardized naming conventions.
• Excellent written and verbal communication skills.
• Ability to handle multiple detailed tasks with high accuracy in a fast‑paced environment.
• Strong planning and organisational capabilities.
• Proficiency with Microsoft Office applications.

Required skills

• Electronic Document Management Systems (EDMS)
• Electronic Trial Master File (eTMF) systems
• Microsoft Office suite