Senior TMF Operations Specialist, EMEA/LATAM

Worldwide Clinical Trials; Ciudad de México; Presencial; MXN 380.000 - 650.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials in Mexico City seeks a TMF Records Management professional to lead TMF operations within a regulated CRO setting. You will ensure quality, compliance and timely archival of essential clinical trial documents, collaborating with global teams and Sponsor counterparts.

The role requires a degree in Life Sciences, 2–4 years’ experience in regulated environments, and strong communication to support audits and regulatory inquiries across the project lifecycle.

Formación

• Understanding of TMF/EDMS principles and regulatory requirements.
• Ability to coordinate activities across global teams and sponsors.
• Strong communication skills for audits, inquiries and document control.

Responsabilidades

• Lead TMF operations for complex studies or sponsor portfolios.
• Coordinate with Project Team and Sponsors to address TMF needs and SME input.
• Oversee TMF Quality Management activities and non-conformance follow-up.
• Contribute to development of project-specific TMF Quality Management documents.
• Prepare and present TMF KPIs and data trends to Project Teams and Sponsors.
• Support regulatory and sponsor audits and audit finding resolutions.

Conocimientos

TMF knowledge

Regulatory compliance

Project coordination

Excellent communication

Stakeholder management

Educación

Bachelor's degree in Life Sciences

Herramientas

Electronic Document Management System (EDMS)

Descripción del empleo

Worldwide Clinical Trials in Mexico City seeks a TMF Records Management professional to lead TMF operations within a regulated CRO setting. You will ensure quality, compliance and timely archival of essential clinical trial documents, collaborating with global teams and Sponsor counterparts.

The role requires a degree in Life Sciences, 2–4 years’ experience in regulated environments, and strong communication to support audits and regulatory inquiries across the project lifecycle.