Central Monitoring Lead — Risk‑Based Study Oversight

FTMEX Fortrea Clinical Development Mexico S.DeR.L.DeC.V.

Ciudad de México

Hybrid

MXN 1,200,000 - 1,800,000

Full time

9 days ago

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Job summary

Fortrea Clinical Development Mexico S.DeR.L.DeC.V. seeks an experienced Central Monitoring Leader to oversee end-to-end centralized monitoring across multiple studies.

You will lead a team of 8–20 professionals, drive risk-based monitoring, review trip reports, and partner with project teams to implement improvements. The role requires strong knowledge of ICH‑GCP, experience with risk assessments and RA/RACT, and excellent communication with global CTLs and project managers.

Qualifications

  • University/College Degree (Life Science preferred) with relevant experience; English proficiency required and fluent in local language.
  • Experience in central monitoring and risk-based monitoring; strong regulatory knowledge (ICH‑GCP).
  • Demonstrated ability to lead and mentor teams of 8–20 professionals.

Responsibilities

  • Review monitoring trip reports for quality, compliance, and best practices.
  • Lead centralized monitoring across site, regional, and study levels; drive risk‑based monitoring.
  • Coach CRAs/IHCRAs; train on trip reports, ICH‑GCP, SOPs, and local work instructions.
  • Develop monitoring plans, dashboards, and analytics; support study risk assessments and RA/RACT contributions.

Skills

Central monitoring
Risk management
Team leadership
Stakeholder communication
ICH‑GCP

Education

University degree in Life Sciences

Tools

MS Office Suite
eTMF reconciliation

Job description

Fortrea Clinical Development Mexico S.DeR.L.DeC.V. seeks an experienced Central Monitoring Leader to oversee end-to-end centralized monitoring across multiple studies.

You will lead a team of 8–20 professionals, drive risk-based monitoring, review trip reports, and partner with project teams to implement improvements. The role requires strong knowledge of ICH‑GCP, experience with risk assessments and RA/RACT, and excellent communication with global CTLs and project managers.

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