TMF Operations Specialist II – Quality & Compliance

Worldwide; Argentina; Remote; ARS 59,687,000 - 89,531,000; Full time

Benefits offered by this job

Health benefits

Professional development

Job summary

Worldwide Clinical Trials is seeking a TMF Records Management professional to support the TMF Operations team. The role involves handling TMF documents across electronic and hard copy formats, ensuring compliance with SOPs and regulatory standards.

The candidate will engage with global project teams, maintain document quality, and contribute to continuous improvement of TMF processes in a CRO setting.

Qualifications

• University degree preferred (Life Science desirable).
• Up to 1-2 years of relevant TMF experience within the CRO/Pharma industry.
• Ability to adhere to standardized document naming conventions.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Word and Excel; familiarity with electronic document repositories.

Responsibilities

• Fulfil the TMF Approver and/or TMF QC Reviewer roles as defined by SOPs.
• Process, review, and resolve rejected TMF documents for complex studies.
• Prepare periodic TMF Quality Control checklists for Project Team review.
• Perform periodic TMF Quality Control to ensure regulatory adherence.

Skills

Data collection

Editing

Communication

Interpersonal skills

Planning

Organizational skills

Education

University Degree

Tools

Microsoft Word

Microsoft Excel

eTMF

Job description

Worldwide Clinical Trials is seeking a TMF Records Management professional to support the TMF Operations team. The role involves handling TMF documents across electronic and hard copy formats, ensuring compliance with SOPs and regulatory standards.

The candidate will engage with global project teams, maintain document quality, and contribute to continuous improvement of TMF processes in a CRO setting.