Director/A De Nóminas Y Administración Laboral - Madrid

Ribbon; Madrid; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote-friendly role. You will support the Centralized Monitoring process, including setup, programming and refreshes of the CM platform, aligned to CMP.

Strong SAS programming and data management knowledge are essential. Responsibilities include developing CM strategies with QTL and KPI elements, creating documentation, reviewing protocols, and collaborating with global stakeholders.

Qualifikationen

• 3+ years in pharmaceutical research and development or related field, preferably centralized monitoring, data management, or biostatistics.
• Experience with SAS programming including macro language.
• Knowledge/ experience working on Cluepoints.
• Ability to work autonomously and engage stakeholders to execute study-level CM processes.
• Strong communication and problem-solving skills.

Aufgaben

• Supports the Centralized Monitoring Lead in developing the CM strategy by identifying CM elements for the study (QTL, KRI, data visualizations, Data Quality Assessments).
• Setup/Program QTL, KRI and Data Quality Assessments according to the CMP.
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification.
• Generate and maintain the CM platform specifications document and file it in eTMF.
• Review and understand the protocol and data sources for the study; understand data transfer specs and data structure.
• Perform peer-review of CM platform setup conducted by colleagues.

Kenntnisse

SAS programming

Communication

Organizational skills

Statistical concepts

Tools

SAS

Cluepoints

Jobbeschreibung

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

EEO Minorities/Females/Protected Veterans/Disabled