Area Manager Madrid Centro | Lidera 80–100 Empleados

Lidl Supermercados SA; Alcalá de Henares; A distancia; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) to oversee centralized monitoring activities in a remote setting. The CMA will work with the Centralized Monitoring Lead to implement CM elements, set up QTL/KRI indicators, and refresh the monitoring platform according to the CMP. Strong SAS skills and English proficiency are required.

The role involves collaboration with global teams, protocol comprehension, and data source handling to ensure quality assessments and regulatory compliance.

Formación

• At least 3 years experience in pharmaceutical R&D or related field.
• 2-3 years SAS experience including macro language.
• Knowledge/experience with Cluepoints.
• Ability to work autonomously and engage with stakeholders.
• Understanding basic statistical concepts.
• Confidentiality of data handling during interactions.
• Experience with data management/biostatistics preferred.
• Experience with relational databases and EDC systems.

Responsabilidades

• Support the Centralized Monitoring Lead in developing the CM strategy by identifying CM elements to implement for the study (QTL, KRI, data visuals, Data Quality Assessments).
• Set up/program QTL, KRI and Data Quality Assessments per the CMP.
• Refresh the Centralized Monitoring Platform at defined frequency to enable signal identification.
• Generate and maintain CM platform specifications documents and file in eTMF.
• Review and understand the study protocol thoroughly.
• Understand data sources and data transfer specifications and data structure.
• Perform and document peer-review of CM platform setup by CMA colleagues.

Conocimientos

Communication skills

Organizational skills

Problem-solving

Interpersonal skills

Initiative

Herramientas

SAS

Cluepoints

EDC Systems

Relational databases

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

EEO Minorities/Females/Protected Veterans/Disabled