CDMX

ICON is a general healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

The Quality Assistance1 role, supports the operational quality and documentation management of clinical trials across CDC and adjacent affiliate countries. This position ensures compliance with regulatory requirements, SOPs, and internal processes while supporting effective trial execution, quality oversight, and coordination across cross-functional teams.

What You Will Do:
- Trial Documentation & eTMF Management
- Oversee clinical trial documentation, including CTA packages for Health Authority (HA) and Ethics Committee (EC) submissions.
- Maintain and ensure compliance of the electronic Trial Master File (eTMF), including timely uploads, quality checks, and archiving at study closeout.
- Support investigator TMF setup and documentation completeness.




- Quality Oversight & Compliance
- Perform compliance checks and process reviews across clinical study activities (e.g., regulatory, feasibility, study start-up, contracts, and trial management).
- Ensure adherence to SOPs, local procedures, and regulatory requirements.
- Document findings and track follow-up actions to closure.
- SOP Deviations Management
- Review and follow up on SOP deviations to ensure accuracy, completeness, and timely resolution.
- Act as system owner for cross-study or multi-site deviations.
- Coordinate stakeholders, track actions, and support deviation trending and reporting.
- Quality Metrics & Reporting
- Support collection, consolidation, and tracking of quality metrics.
- Maintain organized documentation and contribute to dashboards and internal reports.
- Clinical Trial Operations Support
- Assist with trial-related payments and invoice processing.
- Su

📌 Quality Assistance 1 (Ciudad de México)
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📍 Ciudad de México