Psicòleg/A Residència Gent Gran – Cognició I Benestar

Sumar; Gerona; A distancia; EUR 70.000 - 99.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) to lead centralized monitoring activities on sponsor projects in a remote capacity. Strong SAS programming and data management skills are required to program CM elements and support data quality assessments.

The CMA will set up, refresh, and maintain the CM platform per CMP, collaborate with the Centralized Monitoring Lead, and ensure regulatory compliance while communicating with global stakeholders. English proficiency is essential.

Formación

• At least 3 years of experience in pharmaceutical R&D or related field, preferably centralized Monitoring, data management, or biostatistics.
• Experience with SAS including macro language.
• Knowledge/experience with Cluepoints.
• Ability to work autonomously and coordinate with stakeholders to execute CM activities.
• Understanding of basic statistical concepts and data interpretation.
• Ability to maintain data confidentiality and work with limited supervision.
• Excellent written and verbal communication, organizational and problem-solving skills.
• Experience with relational databases and Clinical Data Management and EDC systems.

Responsabilidades

• Supports the Centralized Monitoring Lead in CM strategy development by identifying CM elements for the study (QTL, KRI, data visualizations).
• Setup/Program QTL, KRI and Data Quality Assessments according to the CMP.
• Refresh CM Platform at predefined frequency to enable signal identification.
• Generate and maintain the CM platform specifications document and file it in eTMF.
• Review and understanding of the study protocol is key.
• Understand data sources, transfer specs, and data structure for the study.
• Execute and document peer-review of CM platform setup by CMA colleagues.

Conocimientos

SAS programming

Data management

Biostatistics

Communication

Problem-solving

GxP knowledge

Herramientas

Cluepoints

SAS

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**

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.

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