TMF Operations Associate I — Drive Quality in Global Trials

Worldwide Clinical Trials; Mexico; On-site; MXN 400,000 - 700,000; Full time

Job summary

Worldwide Clinical Trials, a global midsize CRO, seeks a TMF Records Management Specialist to strengthen regulatory alignment and data integrity across studies. You will lead TMF activities, support audits, and collaborate with project teams to ensure timely, compliant documentation while advancing quality management and continuous improvement for diverse therapeutic areas.

Join a mission-driven group that values quality, collaboration, and diverse backgrounds, with opportunities to grow within

Qualifications

• Strong understanding of clinical research principles and TMF standards.
• Ability to plan, organize, and work under pressure.
• Excellent written and verbal communication with internal and external stakeholders.
• Ability to identify pragmatic regulatory compliant solutions.
• Experience in a regulated CRO/pharma environment preferred.

Responsibilities

• Perform RMC Lead Activities across complex studies.
• Communicate with Project Team and Sponsors to assess TMF needs.
• Oversee quality control planning and non-compliance follow-up.
• Develop TMF Quality Management Documents.
• Prepare and present TMF KPIs and data trends.
• Support regulatory and sponsor audits and audit findings.

Skills

TMF/Records Management

Regulatory Compliance

Project Coordination

Communication Skills

Problem Solving

Education

University degree (Life Science preferred)

Job description

Worldwide Clinical Trials, a global midsize CRO, seeks a TMF Records Management Specialist to strengthen regulatory alignment and data integrity across studies. You will lead TMF activities, support audits, and collaborate with project teams to ensure timely, compliant documentation while advancing quality management and continuous improvement for diverse therapeutic areas.

Join a mission-driven group that values quality, collaboration, and diverse backgrounds, with opportunities to grow within