Remote Centralized Monitoring Analyst

Reboot Monkey; Cádiz; Remote; EUR 60,000 - 90,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to work remotely across international sites. The CMA will support setup, programming and refreshes of the Centralized Monitoring platform according to CMP, collaborating with the Centralized Monitoring Lead and client representatives.

Responsibilities include developing CM strategy elements (QTL, KRI, data visualizations), programming QTL/KRI, refreshing CM platform, documenting specifications, and ensuring protocol understanding.

Qualifications

• At least 3 years relevant experience in pharma R&D, centralized Monitoring, data management or biostatistics.
• 2-3 years SAS experience including macro language.
• Knowledge/experience working on Cluepoints.
• Ability to work autonomously and engage with stakeholders to execute CM activities.
• Understanding data sources, transfer specs and data structures is essential.
• Experience with relational databases, preferably Clinical Data Management and EDC Systems.
• Advanced knowledge of federal regulations, Good Clinical Practice and GCDMP.
• Excellent command of English (verbal and written).

Responsibilities

• Supports CM Lead in developing fit-for-purpose CM strategy (QTL, KRI, data visualizations, Data Quality Assessments).
• Setup/Program QTL, KRI and Data Quality Assessments per study CMP.
• Refresh CM platform at defined frequency to enable signal identification.
• Create and maintain CM platform specifications document and file in eTMF.
• Review/provide understanding of study protocol.
• Understand data sources, data transfer specs and data structures.
• Perform peer-review of CM platform setup by colleagues.

Skills

SAS programming

Cluepoints knowledge

Data management

Biostatistics understanding

Communication skills

Tools

SAS macro language

Job description

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to work remotely across international sites. The CMA will support setup, programming and refreshes of the Centralized Monitoring platform according to CMP, collaborating with the Centralized Monitoring Lead and client representatives.

Responsibilities include developing CM strategy elements (QTL, KRI, data visualizations), programming QTL/KRI, refreshing CM platform, documenting specifications, and ensuring protocol understanding.