Associate II – TMF Operations

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

📋 Description

• Execute the roles of “TMF Approver” and/or “TMF QC Reviewer” in line with applicable SOPs and operational practices.

• Process, assess, and address rejected Trial Master File documents for intricate studies or Sponsor portfolios in both electronic and paper formats.

• Create regular TMF Quality Control checklists for review by the Project Team.

• Conduct periodic TMF Quality Control to verify compliance with regulatory requirements, ICH GCP, Sponsor guidelines, and industry best practices.

• Utilize Electronic Document Management and electronic TMF Systems to evaluate, categorize, and manage Essential Documents.

• Frequently collaborate with members of the Worldwide Project Team.

⛳️ Requirements

• Skills in data collection, indexing, and editing.

• Capability to follow standardized document naming conventions.

• Exceptional written and verbal communication abilities.

• Strong interpersonal skills in a dynamic, deadline-driven, and rapidly evolving environment.

• Capacity to manage multiple, highly detailed tasks with outstanding accuracy.

• Strong planning and organizational capabilities.

• Proficiency in Microsoft Word and Excel.

• Ability to attain proficiency in an electronic document repository or eTMF.

• General knowledge of clinical research principles and processes.

• University Degree preferred; Life Science background is desirable.

• Up to 1–2 years of pertinent TMF experience within the CRO/Pharma sector.

🏝️ Benefits

• Supportive and collaborative teams.

• Diverse and inclusive workplace.

• Equal employment opportunities.

• Outstanding employee experiences.

• Opportunity to work with global project teams.