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Remote work

Descripción de la vacante

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to operate in a remote capacity across multiple international locations. The CMA will support the Centralized Monitoring Lead, program QTL/KRI/Data Quality Assessments, and refresh the CM platform to identify signals.

Strong SAS skills and knowledge of Cluepoints are essential as is excellent English communication. The role emphasizes autonomous work with collaboration across global teams, ensuring CM plans follow CMP and regulatory

Formación

• At least 3 years of 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 autonomously and engage stakeholders to execute CM activities.
• Excellent written and verbal English communication.

Responsabilidades

• Support Centralized Monitoring Lead in developing CM strategy and identifying CM elements.
• Set up and program QTL, KRI and Data Quality Assessments per CMP.
• Refresh CM platform at predefined frequency to enable signal identification.
• Generate and maintain CM platform specs and file in eTMF.
• Review protocol and understand data sources, transfer specs and structure.
• Peer-review CM platform setup conducted by colleagues.

Conocimientos

SAS programming

Communication

Organization skills

Cluepoints

Autonomous work

Data integrity

Herramientas

Cluepoints

Descripción del empleo

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 Clinical Data Management and EDC Systems
• Experience communicating with all levels of personnel and participating in collaborative work team (locally and globally).
• Advanced knowledge of federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices.
• Excellent command, both verbal and written, of English

This role is not eligible for UK visa sponsorship

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