Associate II, TMF Operations – LATAM

This is a fully remote position, open to applicants in Argentina, +2 more countries.

📋 Description

• Execute TMF Approver and TMF Quality Control Reviewer responsibilities in line with applicable procedures and work methodologies.

• Handle, assess, and resolve rejected TMF documents for complex studies or sponsor portfolios.

• Oversee essential documents in both electronic and physical formats.

• Create regular TMF Quality Control checklists for review by the project team.

• Perform routine quality checks to ensure compliance with regulatory standards, ICH GCP, sponsor expectations, and industry best practices.

• Evaluate, categorize, index, and process essential documents utilizing electronic document management and eTMF systems.

• Implement consistent document naming and filing conventions to uphold accurate, high-quality trial records.

• Partner with global project teams to resolve documentation challenges and enhance TMF quality.

⛳️ Requirements

• A university degree is preferred, preferably in a life sciences field.

• Up to one to two years of relevant TMF experience in the CRO or pharmaceutical sectors.

• Proficient in English, with outstanding written and verbal communication capabilities.

• Experience in data collection, document indexing, editing, and standardized document naming conventions.

• Strong attention to detail, with the capacity to manage multiple tasks accurately and meet deadlines.

• Effective planning, organizational, and interpersonal skills in a dynamic, fast-paced environment.

• Proficient in Microsoft Word and Excel.

• Familiarity with electronic document repositories or eTMF systems, along with a general understanding of clinical research principles and processes.

🏝️ Benefits

• Equal employment opportunities

• Diverse and inclusive work environment

• Collaborative and supportive teams

• Accessible leadership

• Employee opportunities to succeed and thrive