Remote Bank Customer Support Agent (After Training)

Grupo Constant; Valencia; Remote; EUR 62,000 - 89,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) to manage setup, programming and refreshes of the Centralized Monitoring platform across sponsor projects on a remote basis. The role requires SAS programming and strong communication with global stakeholders.

You will support CM strategy development, implement QTLs/KRIs, review protocols, understand data sources and document CM configurations within eTMF. This position is remote with international teams.

Qualifications

• At least 3 years relevant experience in pharmaceutical R&D, centralized monitoring or related fields.
• 2-3 years SAS experience including macro language.
• Knowledge/experience with Cluepoints.
• Ability to work autonomously and engage with stakeholders to execute study-level CM activities.
• Understanding basic statistical analysis concepts and interpretation of outcomes.
• Maintain confidentiality of data and information.
• Experience with relational databases, preferably Clinical Data Management and EDC Systems.
• Experience communicating with all levels of personnel and collaborating globally.
• Advanced knowledge of federal regulations, Good Clinical Practice.

Responsibilities

• Supports the Centralized Monitoring Lead in CM strategy development for the study.
• 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 CM platform specifications document and file it in eTMF.
• Review and understanding of protocol is key.
• Understand data sources and transfer specifications.
• Execute and document peer-review of CM platform setup.

Skills

SAS programming

Statistical concepts

Communication

Interpersonal skills

Problem solving

Initiative

Autonomous work

Data confidentiality

Data management

Clinical Data Management

Tools

Cluepoints

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

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