Manager, Software Quality Assurance / Testing: Servicenow

Ntt Data, Inc.; Madrid; A distancia; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote, globally available role. The CMA will monitor studies, set up QTL/KRI, and contribute to CM strategies with strong SAS programming and data management skills.

You will collaborate with the CM Lead and clients to ensure timely, compliant monitoring deliverables. The position requires autonomy, excellent English, and experience with centralized monitoring processes and data sources.

Formación

• Minimum 3 years in pharmaceutical R&D or related field, preferably centralized monitoring.
• Experience with SAS programming including macro language.
• Knowledge of Cluepoints and centralized monitoring concepts.

Responsabilidades

• Support CM lead in developing CM strategy and CM elements for studies.
• Setup/Program QTL, KRI and data quality assessments per CMP.
• Refresh CM platform at predefined frequency for signal identification.
• Generate and maintain CM platform specifications and file in eTMF.
• Review study protocol and understand data sources and transfer specs.
• Document peer-review of CM platform setups by CMA colleagues.
• Communicate findings clearly to stakeholders at multiple levels.

Conocimientos

SAS programming

Clinical data management

Communication skills

Herramientas

SAS

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

• 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

• Location : Remote (Work from Anywhere)

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