Air Interface Architect

Ef; Barcelona; À distance; EUR 80 000 - 116 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to support CM strategy development and platform maintenance in a remote role across multiple regions. The candidate will implement QTL, KRI, and data quality assessments, and ensure CM platform specifications are up-to-date within the eTMF system.

The role requires SAS expertise (including macros), experience with Cluepoints, data management, and strong communication skills to collaborate with global stakeholders under GCP/GCDMP

Qualifications

• At least 3 years in pharmaceutical research and development 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 stakeholders to execute CM processes.
• Understanding of basic statistical concepts and interpretation.
• Strong communication and data confidentiality.
• Experience with relational databases and EDC systems.
• Advanced knowledge of GCP, GLP and GCDMP.

Responsabilités

• Supports the Centralized Monitoring Lead in developing the CM strategy for studies (QTL, KRI, data visualizations).
• Set up/program QTL, KRI and Data Quality Assessments according to CMP.
• Refresh Centralized Monitoring Platform at predefined frequency for signal identification.
• Generate and maintain CM platform specifications and file in eTMF.
• Review and understand study protocol and data sources.
• Peer-review CM platform setup by colleagues.

Connaissances

SAS

Cluepoints

Communication

Data management

Biostatistics

Regulatory knowledge

Outils

SAS Macro language

Relational databases

EDC Systems

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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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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