Sr. Data Surveillance Specialist (Remote LATAM)

About the role

Emmes Group, a clinical research organization with business units Emmes (a full-service CRO) and Veridix AI, is hiring a Senior Data Surveillance Specialist (DSS) remotely for its LATAM region. The DSS leads the implementation of Risk-based Quality Management (RbQM) across studies, focusing on centralized monitoring to ensure data integrity oversight. The role also covers developing study dashboards, reports, aggregated data visualizations and key risk indicator (KRI) components.

Key responsibilities

• Act as single point of accountability for applying RbQM in line with study planning, protocol, SOPs, ICH GCP and regulatory requirements.
• Ensure monitoring mitigations for study and data risks are fit for purpose and included in the operational plan.
• Work with Operations to define the oversight plan, with Data Management on automated and manual cleaning checks, and with the Clinical Trial Manager on the CRA strategy.
• Implement central monitoring requirements at study level and interpret analytic signals for study delivery.
• Monitor critical data and processes against quality tolerance limits, define remediation for trends and issues, and create and report study summaries on a defined frequency.
• Accountable for study-level data analytics investigations, vendor deliverables and performance, and comply with all policies and standards.

Required profile

• Bachelor's degree in a science-related field, or equivalent work experience.
• 4-6 years of relevant biotechnology/pharmaceutical industry experience.
• 1-3 years of direct RbQM analytics and process experience.
• 1-3 years of expertise in the clinical drug development process and ICH GCP guidelines and regulations.

Required skills

• Good understanding of graphical techniques used in centralized monitoring visualizations and quality requirements.
• Ability to identify missing data, interpret observed versus expected data and distributions, and spot outliers and atypical patterns.
• Understanding of clinical trials, drug development, risk management and quality requirements.
• Strong influencing, critical thinking, prioritization and communication skills, with effective problem solving and learning agility.