Senior Clinical Data & Risk Monitor

SmartRecruiters, Inc.; Ciudad de México; Presencial; MXN 700.000 - 1.100.000; Jornada completa

Descripción de la vacante

AbbVie is seeking a Senior Central Monitor to analyze and investigate study data using Key Risk Indicators, Quality Tolerance Limits and Data Anomalies to provide early insights for mitigating risks to participant safety and data integrity.

The role collaborates with cross-functional teams including primary site monitors, safety, data sciences, and study leadership to identify root causes and drive interventions, supporting global RBQM processes and system improvements.

Formación

• Bachelor’s degree in related fields including life sciences and risk-based disciplines.
• Minimum of 5 years of clinically related or data trend analysis experience; at least 4 years of clinical research monitoring.
• Experience working in a RBQM model or similar risk-based environment.
• Familiarity with ICH/GCP guidelines related to clinical trials and trial conduct.

Responsabilidades

• Review the protocol and ensure the Integrated Data Review Plan is updated for the central monitor role within the study.
• Provide recommendations during initial Risk Management meetings on KRIs and QTLs.
• Inspect aggregate clinical and operational data from multiple sources and use analytics to uncover insights and patterns.
• Identify significant issues and emerging risks at study site, program, and country levels using KRIs and QTLs.
• Document detected issues and emerging risks with clear action implications.
• Communicate findings to cross-functional stakeholders so follow-up actions can be taken.

Educación

Bachelor’s degree in related fields including life sciences and risk-based disciplines

Descripción del empleo

AbbVie is seeking a Senior Central Monitor to analyze and investigate study data using Key Risk Indicators, Quality Tolerance Limits and Data Anomalies to provide early insights for mitigating risks to participant safety and data integrity.

The role collaborates with cross-functional teams including primary site monitors, safety, data sciences, and study leadership to identify root causes and drive interventions, supporting global RBQM processes and system improvements.