TMF & Clinical Operations Assistant (Hybrid)

IQVIA LLC; Ciudad de México; Híbrido; MXN 180.000 - 260.000; Jornada completa

Descripción de la vacante

IQVIA LLC is seeking a part-time? or hybrid Clinical Documentation Assistant in Mexico City to support the Clinical Research Associates and Regulatory and Start-Up teams with TMF delivery and document handling.

You will assist with document preparation, archiving, and quality checks, ensuring compliance with GCP/ICH. Strong English and MS Office skills are required, and some travel may occur for site visits after training.

Formación

• Bachelor degree in life sciences or healthcare is required.
• 6 months–1 year of clinical research experience (regulatory, COFEPRIS submissions).
• Hybrid work availability and Mexico City location.
• Good written and verbal English language skills.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Strong time management and organizational abilities.
• Ability to collaborate with coworkers, managers and clients.

Responsabilidades

• Assist CRAs and RSU with updating and maintaining TMF and related documents.
• Prepare, handle, distribute, file and archive clinical documentation per SOPs.
• Periodically review study files for completeness.
• Track and manage Clinical Trial Supplies and related data.
• Manage Case Report Forms, queries and clinical data flow.
• Serve as central contact for project communications and documentation.
• May accompany CRAs on site visits after training.

Conocimientos

Communication skills

Time management

Organizational skills

English language proficiency

Educación

Bachelor Degree in Life Science or Healthcare

Herramientas

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Descripción del empleo

IQVIA LLC is seeking a part-time? or hybrid Clinical Documentation Assistant in Mexico City to support the Clinical Research Associates and Regulatory and Start-Up teams with TMF delivery and document handling.

You will assist with document preparation, archiving, and quality checks, ensuring compliance with GCP/ICH. Strong English and MS Office skills are required, and some travel may occur for site visits after training.