Remote Lead Centralized Monitoring & Data Quality Analyst

The Aurum Institute Group; Klerksdorp; Remote; ZAR 1,143,000 - 1,796,000; Full time

Job summary

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) to support centralized monitoring on sponsor projects in a remote capacity. The role emphasizes SAS programming and Cluepoints expertise to set up, program, and refresh the CM platform under the CM Lead.

The CMA will contribute to the CMP, define CM elements like QTLs and KRIs, and collaborate with global stakeholders to ensure data quality and regulatory compliance. Strong English communication and organizational skills are essential.

Qualifications

• At least 3 years relevant experience in pharmaceutical R&D or related field, preferably centralized Monitoring, data management, and/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 study-level CM processes.
• Ability to understand basic statistical analysis concepts and interpret outcomes.
• Advanced knowledge of GCP and Good Clinical Data Management Practices.

Responsibilities

• Supports the Centralized Monitoring Lead in developing the CM strategy by identifying relevant CM elements (QTL, KRI, data visualizations, DQAs).
• Setup/Program QTL, KRI and DQAs according to the CMP.
• Refresh CM Platform at predefined frequency to enable signal identification.
• Generate and maintain CM platform specifications and file in eTMF.
• Review and understand the study protocol and data sources.
• Execute and document peer-review of CM platform setup by colleagues.

Skills

Communication skills

Interpersonal skills

Problem solving

Organizational skills

Autonomy

Tools

SAS Programming

Cluepoints

Relational databases

EDC Systems

Job description

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) to support centralized monitoring on sponsor projects in a remote capacity. The role emphasizes SAS programming and Cluepoints expertise to set up, program, and refresh the CM platform under the CM Lead.

The CMA will contribute to the CMP, define CM elements like QTLs and KRIs, and collaborate with global stakeholders to ensure data quality and regulatory compliance. Strong English communication and organizational skills are essential.