Sr. Data Surveillance Specialist

Emmes Group•Bogota, Capital District, UNAVAILABLE

About The Position

The Sr. Data Surveillance Specialist (DSS) leads the implementation of Risk-based Quality Management (RbQM) across studies, focusing on centralized monitoring to ensure data integrity oversight. The role develops study dashboards, reports, study-specific aggregated data visualizations, and key risk indicator (KRI) components to provide oversight and data interpretation throughout study execution.

Requirements

Bachelor's degree in a science-related field or equivalent work experience.
4–6 years of relevant biotechnology or pharmaceutical industry experience.
1–3 years of direct RbQM analytics and process experience.
1–3 years of expert knowledge of the clinical drug development process, ICH GCP guidelines, and regulations.
Good understanding of graphical techniques used in centralized monitoring visualizations and associated processes and quality requirements.
Ability to identify missing data and understand its implications.
Ability to interpret observed versus expected data and distributions.
Ability to identify and interpret outliers.
Ability to identify and interpret atypical data patterns.
Understanding of clinical trials, drug development, risk management, and associated processes and quality requirements.
Influencing skills and critical thinking for study planning and execution.
Strong focus on delivery.
Ability to set and manage priorities and performance targets.
Excellent verbal and written communication skills.
Ability to understand the impact of technology on studies, use and develop computer skills, and make appropriate decisions.
Effective problem-solving and conflict-resolution skills.
Flexibility and high learning agility.

Responsibilities

Serve as the single point of accountability for embedding RbQM in assigned studies in alignment with study planning, protocols, SOPs, ICH GCP, and regulatory requirements.
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 CRA strategy.
Liaise with cross-functional team members to address actions and issues.
Own study-level data analytics investigations, vendor deliverables, and performance.
Implement centralized 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.