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Quality Assistance 1

  1. Mexico City
JR153933
  1. Clinical Trial Support
  2. ICON Strategic Solutions (FSP)
  3. Remote
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About the role

CDMX

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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.
    • Support local safety reporting activities.
    • Provide administrative and system support (e.g., super user tasks as applicable).

  • Training & Team Coordination

    • Maintain training guides and training matrices, ensuring alignment with role requirements.
    • Track training completion and identify gaps.
    • Coordinate team meetings and support knowledge sharing across the team.

  • Cross-functional Collaboration

    • Partner with CDC, local clinical teams, and other stakeholders to ensure successful trial planning and execution.
    • Drive consistency in processes and eTMF handling across affiliate countries.

Your Profile:

  • Less than 2 years of relevant experience in clinical operations, quality support, or similar roles.
  • Basic understanding of clinical trial processes, documentation, and regulatory requirements.
  • Familiarity with eTMF systems, SOPs, and quality/compliance practices is an advantage.
  • Strong organizational skills and attention to detail, with the ability to manage multiple tasks.
  • Good communication and coordination skills, with a collaborative approach to cross-functional work.
  • Ability to track, document, and follow up on activities in a structured and timely manner.
  • Proficiency in administrative tools and systems (e.g., document management, tracking systems).

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply

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