Security Operations Analyst - 24/7 Detection & Response

Pragmatike; Elche; Remoto; EUR 55.000 - 90.000; Tempo pieno

Descrizione del lavoro

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) for a remote role. You will contribute to the Centralized Monitoring process by setting up, programming, and refreshing the CM platform according to study CMP, and by collaborating with the CM Lead and client to ensure delivery.

The role requires 2–3 years SAS experience (including macro language), knowledge of Cluepoints, and the ability to work autonomously with stakeholders across the project.

Competenze

• At least 2–3 years SAS experience including macro language.
• Knowledge/ experience working on Cluepoints.
• Ability to work autonomously and engage with stakeholders to execute CM activities.
• Understand basic statistical concepts and interpret results.
• Experience with relational databases, preferably CDM and EDC Systems.
• Excellent verbal and written communication skills.

Mansioni

• Setup/Program QTL, KRI, and Data Quality Assessments according to CMP.
• Refresh Centralized Monitoring Platform at predefined frequency to identify signals.
• Generate and maintain CM platform specifications document in eTMF.
• Review and understand study protocol and data sources.

Conoscenze

SAS programming

Communication

Data analysis

Organizational skills

Problem solving

Strumenti

Cluepoints

SAS

Descrizione del lavoro

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

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