TMF Operations Lead for Global Trials (EMEA/LATAM)

Worldwide Clinical Trials; Ciudad de México; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Worldwide Clinical Trials in Mexico City seeks a Team Lead, TMF Operations to ensure regulatory-compliant trial master files and inspection readiness. You will work with global project teams, sponsors, and QA to manage essential documents across multiple studies.

The role drives TMF service delivery for 5–10 studies, monitors KPIs, mitigates risks, and creates quality management documents to support compliant, efficient trial conduct.

Formación

• University Degree preferred (Life Science desirable).
• Combination of education plus 3-5 years of relevant experience.
• In depth knowledge of ICH GCP.
• Experience in supporting GCP inspections (FDA, PMDA, EMA, etc.).
• Experience with TMF/eTMF solutions and regulated environments.

Responsabilidades

• Maintain TMF inspection readiness in line with SOPs and ALCOA.
• Deliver TMF services for 5–10 studies and coordinate with project teams.
• Monitor KPIs and communicate performance to sponsors and teams.
• Identify risks and mitigate them; analyze data for informed decisions.
• Develop project-specific Quality Management Documents.

Conocimientos

Analytical thinking

Interpersonal skills

Mentoring

Attention to detail

Problem solving

Data interpretation

Educación

Bachelor's degree

Life Sciences

Herramientas

Veeva

Trial Interactive

Documentum

Descripción del empleo

Worldwide Clinical Trials in Mexico City seeks a Team Lead, TMF Operations to ensure regulatory-compliant trial master files and inspection readiness. You will work with global project teams, sponsors, and QA to manage essential documents across multiple studies.

The role drives TMF service delivery for 5–10 studies, monitors KPIs, mitigates risks, and creates quality management documents to support compliant, efficient trial conduct.