Associate II, TMF Operations – LATAM
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Job Description
TMF Operations Associate maintaining inspection-ready clinical trial documents for Worldwide Clinical Trials, a global CRO. Reviewing, indexing, and quality-controlling TMF records across sponsor studies.
Responsibilities:
- Perform TMF Approver and TMF Quality Control Reviewer activities in accordance with relevant procedures and working practices
- Process, review, and resolve rejected TMF documents for complex studies or sponsor portfolios
- Manage essential documents in electronic and hard-copy formats
- Prepare periodic TMF Quality Control checklists for project team review
- Conduct regular quality checks to support compliance with regulatory requirements, ICH GCP, sponsor expectations, and industry best practices
- Review, classify, index, and process essential documents using electronic document management and eTMF systems
- Apply consistent document naming and filing standards to maintain accurate, high-quality trial records
- Collaborate with global project teams to address documentation issues and support TMF quality
Requirements:
- A university degree is preferred, ideally in a life science discipline
- Up to one to two years of relevant TMF experience within the CRO or pharmaceutical industry
- Proficiency in English, with excellent written and verbal communication skills
- Experience in data collection, document indexing, editing, and standardized document naming
- Strong attention to detail, with the ability to manage multiple tasks accurately and meet deadlines
- Effective planning, organizational, and interpersonal skills in a fast-paced, changing environment
- Proficiency in Microsoft Word and Excel
- Familiarity with electronic document repositories or eTMF systems
- General understanding of clinical research principles and processes
Benefits:
- Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
- Supportive and inclusive work environment
- Remote work arrangement
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