Centralized Monitoring Analyst — Remote (SAS, Cluepoints)

Lidl Supermercados SA; Alcalá de Henares; Remoto; EUR 60.000 - 90.000; Tempo pieno

Descrizione del lavoro

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) to oversee centralized monitoring activities in a remote setting. The CMA will work with the Centralized Monitoring Lead to implement CM elements, set up QTL/KRI indicators, and refresh the monitoring platform according to the CMP. Strong SAS skills and English proficiency are required.

The role involves collaboration with global teams, protocol comprehension, and data source handling to ensure quality assessments and regulatory compliance.

Competenze

• At least 3 years experience in pharmaceutical R&D or related field.
• 2-3 years SAS experience including macro language.
• Knowledge/experience with Cluepoints.
• Ability to work autonomously and engage with stakeholders.
• Understanding basic statistical concepts.
• Confidentiality of data handling during interactions.
• Experience with data management/biostatistics preferred.
• Experience with relational databases and EDC systems.

Mansioni

• Support the Centralized Monitoring Lead in developing the CM strategy by identifying CM elements to implement for the study (QTL, KRI, data visuals, Data Quality Assessments).
• Set up/program QTL, KRI and Data Quality Assessments per the CMP.
• Refresh the Centralized Monitoring Platform at defined frequency to enable signal identification.
• Generate and maintain CM platform specifications documents and file in eTMF.
• Review and understand the study protocol thoroughly.
• Understand data sources and data transfer specifications and data structure.
• Perform and document peer-review of CM platform setup by CMA colleagues.

Conoscenze

Communication skills

Organizational skills

Problem-solving

Interpersonal skills

Initiative

Strumenti

SAS

Cluepoints

EDC Systems

Relational databases

Descrizione del lavoro

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) to oversee centralized monitoring activities in a remote setting. The CMA will work with the Centralized Monitoring Lead to implement CM elements, set up QTL/KRI indicators, and refresh the monitoring platform according to the CMP. Strong SAS skills and English proficiency are required.

The role involves collaboration with global teams, protocol comprehension, and data source handling to ensure quality assessments and regulatory compliance.