Operario De Producción Remoto | Control De Calidad Digital

Ecobasics Bio Sl; Oña; Remote; EUR 45,000 - 75,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (CMA) for the Cluepoints platform, to work remotely on sponsor projects. You will set up and refresh the CM process, collaborating with the CM Lead and data teams to ensure CMP alignment.

Require 3+ years in pharmaceutical R&D or centralized monitoring, SAS programming including macros, and a proactive, autonomous work style.

Qualifications

• 3+ years of experience in pharmaceutical R&D or centralized monitoring
• Experience with Cluepoints platform
• Ability to work autonomously and engage with stakeholders to execute CM activities
• Understanding of basic statistical concepts and data structures

Responsibilities

• Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP
• Refresh the Centralized Monitoring Platform at predefined frequency
• Generate and maintain CM platform specifications document and file in eTMF
• Review and understanding of protocol is key
• Understand data sources, data transfer specifications and data structure
• Execute and document peer-review of CM platform setup by CMA colleagues

Skills

SAS programming

SAS macro language

Centralized Monitoring (Cluepoints)

Data visualization

Education

Pharmaceutical R&D knowledge

Tools

Cluepoints

Job description

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