13 set - Milano
Iqvia Argentina
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).
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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 le
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