Senior Data Surveillance Specialist

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. The role leads the implementation of Risk-based Quality Management (RbQM) across studies, with a focus on centralized monitoring to ensure data integrity oversight. It covers developing study dashboards, study reports, aggregated data visualizations and key risk indicator (KRI) components.

Key responsibilities

• Serve 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 so that data quality metrics are consistently overseen across multiple studies.
• Interpret analytic signals and monitor critical data and processes against quality tolerance limits, defining remediation for trends and issues.
• Accountable for study-level data analytics investigations, vendor deliverables and performance, and for producing study summaries on a defined frequency.

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 associated quality requirements.
• Ability to identify and interpret missing data, outliers, atypical data patterns and the difference between observed and expected data.
• Strong influencing, critical thinking, prioritization and communication skills, with effective problem solving and learning agility.