Perito Para Su Taller De Barcelona

Linea Directa Aseguradora; Barcelona; Remote; EUR 70,000 - 110,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role. The CMA will set up, program, and refresh the centralized monitoring platform per the CMP, coordinating with the CM Lead and stakeholders across locations.

The role requires 3+ years in pharmaceutical R&D or related fields, SAS programming (including macros) and experience with Cluepoints. Excellent communication and data management skills are essential.

Qualifications

• 3+ years experience in pharmaceutical R&D or related field, with centralized monitoring or data management
• SAS programming experience including macro language
• Experience with Cluepoints and centralized monitoring platforms
• Ability to work autonomously and engage with stakeholders to deliver study-level CM activities
• Strong communication, interpersonal, organizational and problem-solving skills
• High initiative, drive and commitment, with data confidentiality awareness
• Experience with relational databases and EDC systems is preferred

Responsibilities

• Support Centralized Monitoring Lead in developing CM strategy for the study, including QTL, KRIs and data visualizations
• Setup and program QTL, KPI and Data Quality Assessments per CMP
• Refresh the CM platform at predefined frequencies to enable signal detection
• Create and maintain CM platform specifications documents and file in eTMF
• Review and understand study protocol and data transfer specifications
• Understand data sources, data structures and transfer specs for the study
• Document peer-review of CM platform setup by colleagues

Skills

Communication

Interpersonal skills

Organizational skills

Problem solving

Initiative

Tools

SAS

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 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.

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