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Resumo da oferta

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role across multiple locations, including Europe. The CMA will setup and refresh the CM platform, program QTL/KRI and collaborate with the CM Lead to implement study-specific CMPs. Strong SAS skills and experience with Cluepoints are required.

The role involves working with sponsors directly to manage deliveries, reviewing protocols, data sources, and reporting specifications in a fast-paced environment.

Qualificações

• At least 3 years relevant experience in pharmaceutical research and development or related field.
• 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.
• Understanding basic statistical analysis concepts and to interpret their outcome.
• Experience with relational databases.

Responsabilidades

• Supports the Centralized Monitoring Lead (CML) in the development of the fit-for purpose CM strategy by contributing to the identification of CM elements for the study (QTL, KRI, data visualizations, Data Quality Assessments).
• Setup/Program QTL, KRI and Data Quality Assessments according to the 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.

Conhecimentos

SAS programming

Communication

Data management

Biostatistics

Autonomous working

Problem solving

Stakeholder engagement

Cluepoints knowledge

Ferramentas

SAS

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 levels
• Ability to work with limited close supervision.
• Demonstrated communication, interpersonal, organizational and problem-solving skills
• High levels of initiative, drive and commitment.
• Prior experience in a Data Management related field is required
• Experience with relational databases, preferably