Code 10 Driver

Vkb Group; South Africa; Remote; ZAR 1,467,000 - 1,957,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) for a remote role, focusing on the setup, programming and refresh of the Centralized Monitoring platform. You will work directly with clients on study-level CM activities and contribute to CMP-driven deliverables.

The role requires SAS programming experience, strong communication, autonomy and ability to collaborate with global teams. Candidates should have 3+ years in pharma R&D and knowledge of regulatory practices.

Qualifications

• 3+ years in pharma R&D or related field with centralized monitoring, data management or biostatistics.
• 2–3 years SAS experience including macro language.
• Knowledge/experience with Cluepoints.
• Autonomous with ability to engage with stakeholders to deliver study-level CM activities.
• Understanding of basic statistical concepts and interpretation of results.
• Maintain data confidentiality and work with limited supervision.
• Excellent communication, interpersonal, organizational and problem-solving skills.
• High initiative, drive and commitment; prior data management experience preferred.
• Experience with relational databases, Clinical Data Management and EDC Systems.
• Experience communicating with all levels and collaborating across teams.
• Strong knowledge of GCP, CDMA/CDM practices and regulatory requirements.
• Excellent written and verbal English.

Responsibilities

• Setup, program and refresh the Centralized Monitoring platform per CMP.
• Assist CM Lead in developing CM strategy and identifying CM elements.
• Set up QTL, KRI and Data Quality Assessments per CMP.
• Refresh CM platform at predefined frequencies to identify signals.
• Generate and maintain CM platform specifications and file in eTMF.
• Review study protocol and understand data sources and transfer specs.
• Peer-review CM platform setup performed by colleagues.

Skills

SAS programming

Communication

Organisation

Data management

Biostatistics

Stakeholder engagement

Tools

Cluepoints

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.

EEO Minorities/Females/Protected Veterans/Disabled