Pega Architect/Lead Developer - Ey Gds Spain - Hybrid

Ey Gds

Málaga

À distance

EUR 48 000 - 75 000

Plein temps

Il y a 5 jours
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Résumé du poste

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) for a remote role. You will support CM strategy, program QTL/KRI, and refresh the CM platform, ensuring CMP alignment and data integrity across studies.

The role demands strong SAS programming skills, attention to protocol details, and effective communication with sponsors and the CMA team.

Qualifications

  • At least 3 years of pharma R&D or related field experience, preferably in centralized Monitoring, data management, and/or biostatistics.
  • 2–3 years SAS experience including macro language.

Responsabilités

  • 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

Connaissances

SAS programming
Centralized Monitoring
Data management
KRI
QTL

Outils

SAS macros

Description du poste

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
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