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

📋 Description

• Execute TMF Approver and TMF Quality Control Reviewer duties in line with established procedures and operational practices.

• Process, examine, and resolve rejected TMF documents for intricate studies or sponsor portfolios.

• Oversee essential documents in both electronic and physical formats.

• Create periodic TMF Quality Control checklists for the project team’s evaluation.

• Perform regular quality assessments to ensure adherence to regulatory standards, ICH GCP, sponsor expectations, and industry best practices.

• Review, categorize, index, and manage essential documents utilizing electronic document management and eTMF systems.

• Implement consistent naming and filing conventions to ensure the accuracy and high quality of trial records.

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

⛳️ Requirements

• A university degree is preferred, especially in a life science field.

• Up to one to two years of pertinent TMF experience in the CRO or pharmaceutical sector.

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

• Background in data collection, document indexing, editing, and standardized document naming practices.

• Exceptional attention to detail, capable of accurately managing multiple tasks while meeting deadlines.

• Strong 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.

• General knowledge of clinical research principles and processes.

🏝️ Benefits

• Equal employment opportunities irrespective 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 any other class protected by applicable law.

• A supportive and inclusive work environment.

• Remote work arrangement.