Chemical Engineering Intern — Hands-On Training

Placements24; Klerksdorp; Remote; ZAR 1,489,000 - 1,985,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (CMA) for remote work to support the Centralized Monitoring process using Cluepoints. You will program and refresh CM elements such as QTL and KRIs, align CM activities to the CMP, and ensure CM specifications are documented in the eTMF.

Strong SAS programming and knowledge of study data structures are essential. You will work with a CM Lead and stakeholders to implement CM strategies, review protocols, and maintain high data integrity while

Qualifications

• Minimum 3 years in pharmaceutical research and development or related field with centralized monitoring
• Proven SAS programming ability including macro language
• Experience with Cluepoints and centralized monitoring processes

Responsibilities

• Support CM Lead in developing CM strategy and identify CM elements (QTL, KRI, data visualizations)
• Set up/program QTL, KRI, and Data Quality Assessments per CMP
• Refresh the CM platform at predefined frequency to enable signal detection
• Generate CM platform specifications and file in eTMF
• Review protocol and understand data sources and transfer specifications
• Perform peer-review of CM platform setup
• Communicate with stakeholders to ensure study objectives are met

Skills

SAS programming

Cluepoints experience

Communication

Data management

Stakeholder engagement

Autonomy

Biostatistics understanding

Tools

Centralized Monitoring Platform (CMP)

SAS Macros

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

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 is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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