Clinical Monitoring Analyst (Cluepoints) - Remote

IQVIA; Shefford; Remote; GBP 40,000 - 60,000; Full time

Job summary

A global clinical research organization in Shefford is seeking a Lead Programmer as a Centralized Monitoring Analyst. You will support the Centralized Monitoring Lead by developing strategies and managing the setup and programming of the Centralized Monitoring platform. Candidates should have strong communication skills, extensive experience in SAS programming, and the ability to work autonomously while engaging with stakeholders. This role does not qualify for UK visa sponsorship.

Qualifications

• At least 3 years of experience in pharmaceutical research and development.
• 2-3 years of experience with SAS, including macro language.
• Ability to engage with stakeholders for centralized monitoring activities.

Responsibilities

• Support the Centralized Monitoring Lead in developing CM strategy.
• Setup/Program Quality Tolerance Limits and Key Risk Indicators.
• Maintain specifications document for the Centralized Monitoring Platform.

Skills

SAS programming

Strong communication skills

Organizational skills

Autonomous working

Problem-solving skills

Data management knowledge

Collaboration skills

Statistical analysis understanding

Tools

Cluepoints

Clinical Data Management Systems

EDC Systems

Job description

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

• 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

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com