Experto/A En Ofimática Para Oposiciones — 100% Remoto

Ucademy; Madrid; Remote; EUR 62,000 - 80,000; Full time

Job summary

Ucademy is seeking a Clinical Monitoring Analyst (Cluepoints) for a fully remote position spanning multiple international sites including Madrid, London and Beyond. You will support the CM strategy, develop QTL/KRI data quality assessments, and maintain CM platform specs, collaborating with study teams and data management to ensure high-quality monitoring.

The candidate should have 3+ years in pharma R&D, 2–3 years SAS (including macros), Cluepoints knowledge, and strong English communication

Qualifications

• At least 3 years in pharmaceutical research and development or related field, preferably centralized Monitoring, data management, or biostatistics.
• 2–3 years SAS experience including macro language.
• Knowledge/experience working on Cluepoints.
• Ability to work autonomously and engage with stakeholders to execute study-level centralized monitoring.
• Ability to understand basic statistical concepts and interpret outcomes.
• Experience with data management related field and relational databases/EDC systems.
• Excellent command of English, both written and verbal.

Responsibilities

• Supports the Centralized Monitoring Lead in developing the CM strategy by identifying CM elements for the study (QTL, KRI, data viz, data quality assessments).
• Set up/program QTL, KRI and Data Quality Assessments per the CMP.
• Refresh Centralized Monitoring Platform at predefined frequency to enable signal identification.
• Generate and maintain CM platform specifications document and file in eTMF.
• Review and understand the study protocol as a key requirement.
• Understand data sources, transfer specs, and data structure for the study.
• Execute and document peer-review of CM platform setup by colleagues.

Skills

SAS programming

Autonomous working

Communication skills

Problem solving

Stakeholder collaboration

Tools

SAS (macro language)

Cluepoints

Relational databases

EDC systems

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

Main responsibilities

• 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

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