Sr. Data Surveillance Specialist

Overview

Sr. Data Surveillance Specialist

Be Part of One Team, One Purpose.

At Emmes Group , we’re shaping the future of clinical research— where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence , we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.

Through our two business units— Emmes, a full-service CRO , and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.

We believe that every clinical breakthrough starts with people —people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation , ensuring that every challenge is met with perseverance and accountability.

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.
Responsibilities

• 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

If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact , join us and be part of something bigger. One Team, One Purpose.

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