Associate II, TMF Operations – Europe/LATAM

This is a fully remote position, open to applicants in Croatia.

📋 Description

• Assume the roles of "TMF Approver" and/or "TMF QC Reviewer"

• Process, assess, and address any rejected Trial Master File (TMF) documents

• Create periodic TMF Quality Control checklists for the Project Team's review

• Conduct regular TMF Quality Control to ensure compliance with regulatory standards

• Collaborate with various Electronic Document Management Systems to review and manage Essential Documents

⛳️ Requirements

• Preferred University Degree (Life Science is a plus)

• 1-2 years of relevant TMF experience in the CRO/Pharma sector

• Strong skills in data collection, indexing, and editing

• Excellent written and verbal communication abilities

• Strong interpersonal skills

• Ability to manage multiple tasks with high accuracy

• Strong planning and organizational capabilities

• Proficiency in Microsoft Word and Excel

• Ability to develop skills in using an electronic document repository or eTMF

🏝️ Benefits

• A diverse and inclusive work environment

• Opportunities for professional development