Planificador De Producción Senior - 100% Remoto

Lácteas García Baquero; Ciudad Real; Teletrabalho; EUR 81 000 - 107 000; Tempo integral

Resumo da oferta

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to join a sponsor-dedicated project. The role requires strong SAS programming skills and familiarity with Cluepoints, supporting the Centralized Monitoring Lead in delivering CM capabilities across studies.

The work involves setting up CM elements, programming QTLs and KRIs, and refreshing platforms to identify signals. Strong communication and confidentiality are essential in this client-facing position.

Qualificações

• 3+ years of 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 relevant stakeholders to execute study-level centralized monitoring activities.
• Ability to understand basic statistical analysis concepts and interpret their outcomes.
• Ability to maintain confidentiality of data and information during interactions with staff.

Responsabilidades

• Supports the Centralized Monitoring Lead (CML) in developing the CM strategy by identifying relevant CM elements (QTLs, KRIs, data visualizations, and data quality assessments).
• Setup/Program QTL, KRI, and Data Quality Assessments per study CMP.
• Refresh the Centralized Monitoring Platform at predefined frequencies to enable signal identification.
• Generate and maintain CM platform specifications documents and file in eTMF.
• Review and understand the study protocol and data transfer specifications.

Conhecimentos

SAS programming

Macro language

Cluepoints knowledge

Autonomous working

Stakeholder engagement

Biostatistics concepts

Descrição da oferta de emprego

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