Product Manager — Precision Enzymes & Emerging Technologies

Watchmakergenomics; Cape Town; Remote; ZAR 1,469,000 - 1,959,000; Full time

Job summary

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) with strong SAS programming skills to manage the setup, programming and refreshes of the Centralized Monitoring platform on sponsor-dedicated projects. You will work directly with clients to deliver CM processes per CMP.

The role requires 3+ years in pharmaceutical R&D or related fields, SAS with macro language, and knowledge of Cluepoints. Strong communication and autonomous work style are essential.

Qualifications

• At least 3 years relevant experience in pharmaceutical R&D or related field, preferably centralized Monitoring, data management, and/or biostatistics.
• 2-3 years SAS experience including macro language.
• Knowledge/experience working on Cluepoints.
• Ability to work autonomously and engage with 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

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 (QTL, KRI, 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

Skills

SAS programming

Cluepoints knowledge

Data management

Biostatistics

Communication skills

Statistical concepts

Relational databases

Collaboration

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

• 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