Quality Leader: Software & Electronics Automation

LHH Recruitment Solutions; Tarragona; Remote; EUR 60,000 - 90,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to support centralized monitoring on sponsor projects. You will program CM elements, including QTLs and KRIs, and refresh the CM platform to flag signals while aligning with the CMP.

Strong SAS skills and ability to work with clients are essential for this remote role. Responsibilities include collaborating with the CM Lead, reviewing protocols, understanding data sources, and maintaining CM documentation.

Qualifications

• At least 3 years in pharma R&D or centralized monitoring.
• 2–3 years SAS experience including macro language.
• Experience with Cluepoints platform.
• Able to work autonomously with stakeholders on study CM tasks.
• Excellent English, verbal and written communication.
• Knowledge of Good Clinical Practice and data management principles.

Responsibilities

• Support the Centralized Monitoring Lead in CM strategy development.
• Set up/program QTLs, KRIs and data quality assessments per CMP.
• Refresh the CM platform at predefined frequency to identify signals.
• Generate and maintain CM platform specifications documents.
• Review study protocol and understand data sources and transfer specs.
• Collaborate with CMA colleagues and global project teams.

Skills

SAS programming

Centralized Monitoring

Data management

Cluepoints

Stakeholder communication

Tools

SAS

EDC systems

Relational databases

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 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