Auditor/A Jefe Eu-Ets Madrid (F/M/D)

Tüv Süd Ag; Barcelona; Remote; EUR 45,000 - 75,000; Full time

Job summary

IQVIA is seeking a Remote Centralized Monitoring Analyst (Cluepoints). This role focuses on setup, programming, and refreshing the CM platform according to the study CMP, with strong SAS skills and experience in Cluepoints.

You will work with the client directly on deliveries, supporting the CM strategy and ensuring data integrity across sites and studies. Fluency in English and excellent coordination are required.

Qualifications

• 3+ years in pharmaceutical R&D or Centralized Monitoring.
• 2-3 years SAS experience including macro language.
• Experience with Cluepoints platform.
• Ability to work autonomously and coordinate with stakeholders.
• Strong communication, organization and problem-solving skills.

Responsibilities

• Supports the Centralized Monitoring Lead in CM strategy development.
• Setup/Program QTL, KRI, and Data Quality Assessments per CMP.
• Refresh Centralized Monitoring Platform to enable signal identification.
• Document CM platform specifications and file in eTMF.
• Understand protocol and data sources for the study.
• Peer-review CM platform setup by colleagues.

Tools

Cluepoints

SAS

eTMF

EDC Systems

Relational databases

Job description

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

• 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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