[Hiring] Sr. Data Surveillance Specialist @Emmes Group

Role Description

The Sr. Data Surveillance Specialist (DSS) will lead the implementation of Risk-based Quality Management (RbQM) across studies with focus on centralized monitoring to ensure data integrity oversight. The DSS will develop study dashboards, study reports, study-specific aggregated data visualizations and key risk indicator (KRI) components to provide oversight and data interpretation through the execution of a study.

• Single point of accountability to embed the application of RbQM aligned with the study planning, study protocol, SOP, ICH GCP, and regulatory requirements for assigned studies.
• Ensure monitoring mitigations to study and data risks are fit for purpose and included in the appropriate operational plan.
• Work with Operations team to define oversight plan.
• Work with Data Management to ensure fit for purpose automated and manual cleaning checks in place.
• Work with Clinical Trial Manager to define CRA strategy.
• Liaise with cross functional team members to address actions and issues.
• Accountable for study level data analytics investigations, vendor deliverables and performance.
• Implement central monitoring requirements at the study level to ensure consistent approach and oversight to the data quality metrics on multiple studies.
• Interpret impact of analytic signals for study delivery during the execution of a trial.
• Monitor critical data and critical process for correct Quality Tolerance Limit measures.
• Define remediation to address trends, signals, and issues within the data.
• Accountable for creating and reporting study summary on defined frequency.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• Bachelor's Degree Science related field, or equivalent work experience. Required
• 4-6 years of relevant biotechnology/pharmaceutical industry experience. Required
• 1-3 years with direct RBQM analytics and process experience. Required
• 1-3 years Expert of clinical drug development process as well as ICH GCP guidelines, and regulations. Required
• Demonstrates good understanding of graphical techniques used in centralized monitoring visualizations and other associated processes and quality requirements. High
• Identification and understanding of the implications of missing data. High
• Interpretation of observed vs expected data and distributions. High
• Identification and interpretation of outliers. High
• Identification and interpretation of atypical data patterns. High
• Demonstrates understanding of clinical trial, drug development, risk management and other associated processes and quality requirements. High
• Influencing skills and critical thinking to planning and execution of a study. High
• Strong focus on delivery. High
• Able to set and manage priorities and performance targets. High
• Excellent verbal and written communication skills. High
• Understand the impact of technology on studies and use and develop computer skills while making appropriate decisions. High
• Effective problem solving and conflict resolution. High
• Flexible high learning agility. High

Company Description