Emmes Group

CRO services and AI-driven trial infrastructure

Senior Data Surveillance Specialist

Clinical Research OperationsPosted on Nov 11

Full-timeNo salary listed

About the Job

Requirements

A Bachelor's degree in a science-related field, or equivalent work experience, is required.
Four to six years of relevant biotechnology or pharmaceutical industry experience is required.
One to three years of direct risk-based quality management analytics and process experience is required.
One to three years of expertise in the clinical drug development process, ICH GCP guidelines, and regulations is required.
Demonstrate understanding of graphical techniques used in centralized monitoring visualizations and associated processes and quality requirements.
Identify missing data and understand its implications.
Interpret observed versus expected data and distributions.
Identify and interpret outliers.
Identify and interpret atypical data patterns.
Demonstrate understanding of clinical trials, drug development, risk management, and associated processes and quality requirements.
Use influencing skills and critical thinking in study planning and execution.
Set and manage priorities and performance targets.
Communicate effectively verbally and in writing.
Understand the impact of technology on studies, develop computer skills, and make appropriate decisions.
Apply effective problem-solving and conflict-resolution skills.
Demonstrate flexibility and high learning agility.

Responsibilities

Serve as the single point of accountability for embedding risk-based quality management aligned with study planning, the study protocol, standard operating procedures, ICH GCP, and regulatory requirements for assigned studies.
Ensure monitoring mitigations for study and data risks are fit for purpose and included in the appropriate operational plan.
Work with the Operations team to define the oversight plan.
Work with Data Management to ensure fit-for-purpose automated and manual cleaning checks are in place.
Work with the Clinical Trial Manager to define the clinical research associate strategy.
Liaise with cross-functional team members to address actions and issues.
Be accountable for study-level data analytics investigations, vendor deliverables, and vendor performance.
Implement central monitoring requirements at the study level to ensure a consistent approach and oversight of data quality metrics across multiple studies.
Interpret the impact of analytic signals on study delivery during trial execution.
Monitor critical data and critical processes for correct Quality Tolerance Limit measures.
Define remediation to address data trends, signals, and issues.
Create and report study summaries at the defined frequency.
Perform other duties as assigned.
Comply with all policies and standards.

Overview

Sr. Data Surveillance Specialist

REMOTE - LATAM

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.

CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/

About the Company

Emmes Group

CRO services and AI-driven trial infrastructure

Emmes Group combines a contract research organization (CRO) with an AI arm to support clinical research globally. The CRO Emmes provides study design, patient recruitment, data collection, statistics, and regulatory support, while Veridix AI builds software tools to plan, manage, and analyze trials using artificial intelligence. It differentiates itself by offering both hands-on trial services and an integrated AI-powered platform, backed by a long history dating to 1977 and a global health focus. Its goal is to modernize clinical research to make trials faster, safer, and more accessible for patients around the world.

Company size: 11-50
Company stage: Not listed
Total funding: Not listed
Headquarters: Rockville, MD
Founded: 2024

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