Lead Clinical Monitoring Analyst (Cluepoints) - Remote

Fundació Pere Tarrés; Barcelona; Remote; EUR 62,000 - 98,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote, sponsor-driven project. The CMA will set up and refresh the Centralized Monitoring platform, program QTL/KRI/Data Quality Assessments, and ensure alignment with the study CMP.

Strong SAS and Cluepoints experience are required, with data management and regulatory knowledge. You will work with the Centralized Monitoring Lead and global teams to ensure data integrity, protocol understanding, and timely deliveries.

Qualifications

• 2-3 years SAS experience including macro language.
• Knowledge/ experience working on Cluepoints.
• Ability to work in an autonomous way and engage with relevant stakeholders.
• Ability to understand basic statistical analysis concepts and to interpret their outcome.
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.

Responsibilities

• Supports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of the relevant CM elements to be implemented for the study (Quality Tolerance Limits (QTL), Key Risk Indicators, data visualizations and Data Quality Assessments)
• Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification
• Generate and maintain the Centralized Monitoring Platform specifications document and file it in eTMF
• Review and understanding of protocol is key
• Understand the data sources for the study, the data transfer specifications and the data structure
• Execute and document peer-review of CM platform setup done by other CMA colleagues

Skills

SAS programming

SAS macro language

Cluepoints

Centralized monitoring

Communication

Data management

Statistical concepts

Autonomous working

Cross-functional collaboration

Problem solving

Tools

Cluepoints

EDC systems

Relational databases

Job description

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote, sponsor-driven project. The CMA will set up and refresh the Centralized Monitoring platform, program QTL/KRI/Data Quality Assessments, and ensure alignment with the study CMP.

Strong SAS and Cluepoints experience are required, with data management and regulatory knowledge. You will work with the Centralized Monitoring Lead and global teams to ensure data integrity, protocol understanding, and timely deliveries.