Plaça De Tècnic Superior (Barcelona) Cido

Generalitat De Catalunya - Escola D'Administració Pública De Catalunya (Eapc); Barcelona; Remoto; EUR 55.000 - 85.000; Tempo pieno

Descrizione del lavoro

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to remotely manage the setup, programming and refresh of the Centralized Monitoring platform across sponsor projects. The role demands strong SAS programming skills and solid communication with clients and CM teams.

You will contribute to CM strategy, interpret protocol data, and ensure data sources and DQA procedures align with CMP requirements while working autonomously in a global setting.

Competenze

• 3+ years of experience in pharmaceutical R&D or related fields, preferably centralized monitoring, data management or biostatistics.
• 2-3 years SAS experience including macro language.
• Knowledge/experience with Cluepoints.
• Ability to work autonomously and engage with stakeholders to execute CM activities.
• Understanding of basic statistical concepts and their interpretation.
• Ability to maintain confidentiality of data and information.
• Ability to work with limited close supervision.
• Demonstrated communication and interpersonal skills.

Mansioni

• Supports the Centralized Monitoring Lead in developing CM strategy by identifying CM elements for the study (QTL, KRI, data visualizations, DQA).
• Setup/Program QTL, KRI and DQA according to the study CMP.
• Refresh CM platform at predefined frequency to enable signal identification.
• Generate and maintain CM platform specifications and file in eTMF.
• Interpret study protocol and understand data sources and data transfer specs.
• Document peer-review of CM platform setups by CMA colleagues.
• Collaborate with clients and CM team to deliver study-level CM activities.

Conoscenze

Autonomous work

Effective communication

Interpersonal skills

Formazione

Bachelor's/Master's in life sciences or biostatistics

Strumenti

SAS

Cluepoints

Descrizione del lavoro

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,