E-Government Implementierungsberater – Remote/Hybrid

Deutsche Telekom; Gijón; Remote; EUR 58,000 - 80,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role. The CMA will manage centralized monitoring setup, programming, and refreshes according to the CMP, collaborating with the CM Lead and client on deliverables.

The position requires 2–3 years SAS experience (including macros), strong communication, and the ability to work autonomously across diverse study sites and data sources.

Qualifications

• Minimum 3 years relevant experience in pharmaceutical R&D or related field with centralized monitoring.
• 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 of basic statistical concepts and data sources for studies.

Responsibilities

• Supports the Centralized Monitoring Lead in developing CM strategy for the study.
• Setup/Program QTL, KRI and Data Quality Assessments per CMP.
• Refresh CM Platform at predefined frequencies for signal detection.
• Generate and maintain CM platform specifications and file in eTMF.
• Review protocol and understand study data transfer specifications.
• Peer-review CM platform setup by colleagues.

Skills

SAS programming

Communication skills

Organization skills

Cluepoints experience

Autonomous working style

SAS macro language

Tools

SAS Macro Language

Job description

Clinical Monitoring Analyst (Cluepoints) - Remote

London, United Kingdom
Budapest, Hungary
Reading, Berkshire, United Kingdom
Bloemfontein, South Africa
Dublin, Ireland
Centurion, South Africa
Barcelona, Spain
Sofia, Bulgaria
Madrid, Spain
Full time
R

This unique role within IQVIA lends itself to a Lead programmer on Cluepoints called Centralized Monitoring Analyst (CMA) with strong communication and organisation skills. Having experience with SAS programming is necessary.

This role is part of a sponsor dedicated project where you will be working with the client directly to manage deliveries.

The CMA contributes to the execution of the Centralized Monitoring process by performing the setup, programming and refresh(es) of the Centralized Monitoring platform, according to the study-specific Centralized Monitoring Plan (CMP).

Main responsibilities include:

• 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

Experience:

• At least 3 years relevant experience in the area of pharmaceutical research and development or related field preferably in centralized Monitoring, data management, and/or biostatistics
• 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 to execute activities related to study level centralized monitoring process.
• Ability to understand basic statistical analysis concepts and to interpret their outcome.
• Ability to maintain confidentiality of data and information during interactions with staff at all