Stage Recrutement It À Barcelone — Sourcing & Entretiens

Extia Group; Barcelona; Remote; EUR 60,000 - 90,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to join a sponsor-dedicated project remotely. You will setup, program and refresh the Centralized Monitoring platform, aligning with the CMP and QA requirements. Strong SAS scripting and data management expertise are essential.

You will collaborate closely with the Centralized Monitoring Lead and client teams to ensure CM deliverables, data integrity and regulatory compliance across multiple study sites.

Qualifications

• 3+ years of experience in pharmaceutical R&D or related field, preferably centralized monitoring, data management, or biostatistics
• 2-3 years SAS experience including macro language
• Experience with Cluepoints
• Ability to work autonomously and coordinate with stakeholders
• Strong communication, interpersonal, organizational and problem-solving skills
• High initiative and commitment
• Experience with data management and relational databases (CDM/EDC)
• Experience communicating with all levels of staff and cross-functional teams
• Familiarity with GCP/ICH regulatory requirements and GxP
• Excellent written and verbal English skills

Responsibilities

• Set up, program and refresh the Centralized Monitoring platform per CMP
• Assist in developing CM strategy and identify CM elements (QTL, KRI, data visualizations)
• Configure QTL, KRI and DQA per CMP and generate CM platform specs document
• Review study protocols and understand data sources, transfer specs and data structure
• Collaborate with CMA colleagues and perform peer-review of CM platform setup

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).

• 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

• 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, organisational 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**

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