Ai Solutions Architect & Client Solutions Director (Remote)

Oliver Agency; Madrid; Remote; EUR 60,000 - 95,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role. The CMA collaborates with the Centralized Monitoring Lead to ensure CM plans are executed, with setup, programming and regular refreshes of the CM platform across studies.

You will work directly with clients on sponsor projects, applying regulatory standards and CF/ICH guidelines while maintaining data integrity and security. Excellent English communication is essential.

Qualifications

• This role requires at least 3 years in pharmaceutical research and centralized monitoring or related fields.
• 2-3 years SAS experience including macro language is required.
• Experience with Cluepoints and QA of CM platform setups is preferred.
• Excellent written and verbal English with strong communication skills.

Responsibilities

• Support the Centralized Monitoring Lead in developing CM strategy for the study.
• Set up and program QTL, KRI and Data Quality Assessments according to the CMP.
• Refresh the CM platform at predefined frequency to enable signal detection.
• Generate and maintain CM platform specifications documents.
• Review study protocol and understand data sources and transfer specs.
• Peer-review CM platform setup done by colleagues.

Skills

SAS programming

Cluepoints experience

Data management

Good Clinical Practice

Communication skills

English proficiency

Education

Bachelor's degree in a relevant field

Tools

Cluepoints platform

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, 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