Senior Data Surveillance Specialist

Job Summary

Leading the implementation of Risk-based Quality Management (RbQM) across studies, the full-time Senior Data Surveillance Specialist will ensure data integrity oversight through the development of dashboards, reports, and visualizations while collaborating with cross-functional teams in a remote work environment.

Key responsibilities

• Serve as the single point of accountability for embedding RbQM aligned with study protocols and regulatory requirements
• Define oversight plans and ensure monitoring mitigations for study and data risks are included in operational plans
• Conduct study level data analytics investigations and implement central monitoring requirements to maintain data quality metrics

Required qualifications

• 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 clinical drug development processes and ICH GCP guidelines
• Strong understanding of graphical techniques for centralized monitoring visualizations