Especialista En Seguridad De Proyectos It (Híbrido Madrid)

It Partner; Madrid; Remote; EUR 45,000 - 75,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role. The CMA will manage CM setup, programming, and refreshes of the CM platform as per the CMP, collaborating with the client and study team.

Key duties include developing CM strategy elements, programming QTLs and KRIs, updating CM specifications, and ensuring protocol understanding and data-source awareness throughout the project.

Qualifications

• 3+ years in pharmaceutical research and development or related field.

Responsibilities

• Supports the Centralized Monitoring Lead in developing the CM strategy for the study.

Skills

SAS programming

Cluepoints

Centralized Monitoring

Data management

Biostatistics

Communication skills

Autonomous working

Tools

SAS

Cluepoints platform

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