Quantitative Analyst: Real-Time Risk & Pricing Modeling

Prima; Madrid; Remote; EUR 52,000 - 68,000; Full time

Job summary

Prima is seeking a Clinical Monitoring Analyst (CMA) to support centralized monitoring across studies in a fully remote capacity. You will contribute to CM strategy, develop QTL/KRI frameworks, and maintain CM platform documentation.

Strong SAS and Cluepoints experience are essential, as is familiarity with data management and GxP practices. Your role involves collaborating with global stakeholders, understanding study data sources, and ensuring compliant CM processes across the project

Qualifications

• 3+ years in pharma R&D or related field with centralized monitoring, data mgmt or biostatistics.
• 2-3 years SAS experience including macro language.
• Experience with Cluepoints and data management concepts.
• Ability to work autonomously and with stakeholders on study CM activities.
• Strong knowledge of data sources, transfer specs and CM platform concepts.

Responsibilities

• Support CM Lead in developing CM strategy with QTL, KRI, data visuals.
• Set up QTL, KRI and data quality assessments per CMP.
• Refresh CM platform at defined frequency for signal detection.
• Generate and maintain CM platform specifications and file in eTMF.
• Review protocol and understand data sources and transfer specs.

Skills

SAS

Data interpretation

Communication skills

Problem solving

Statistical concepts

Tools

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

Clinical Monitoring Analyst (CMA) 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 required:

• 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