Jefe/A De Recepción – Residencia Internacional, Barcelona

Avanjobs; Barcelona; Remote; EUR 60,000 - 90,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (CMA) with Cluepoints expertise to join a sponsor dedicated project in a remote capacity. You will contribute to the Centralized Monitoring process by setting up QTLs, KRIs and data quality assessments, and by supporting the CM strategy under the guidance of the CML.

The role requires 2–3 years SAS experience (including macros), knowledge of Cluepoints, and strong communication and organizational skills to work autonomously with stakeholders across

Qualifications

• 3+ years in pharma R&D or related field, preferably centralized monitoring, data management or biostatistics.
• 2-3 years SAS experience including macro language.
• Knowledge/ experience working on Cluepoints.
• Strong communication and organisational skills; autonomous work style.

Responsibilities

• Support the Centralized Monitoring Lead (CML) in developing the CM strategy, contributing to CM elements like QTLs, KRIs, data visuals and DQA.
• Set up/program QTL, KRI and data quality assessments per CMP.
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal detection.
• Generate and maintain CM platform specifications documents and file in eTMF.
• Review and understand the study protocol.
• Understand data sources, transfer specs and data structure; perform peer-review of CM platform setups.

Skills

SAS programming

Cluepoints experience

Communication

Organisation

Autonomy

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.