Clinical Monitoring Analyst (CMA)
Clinical Monitoring Analyst (CMA)
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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. The role can be based remotely from numerous European countries or South Africa.
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 studyspecific Centralized Monitoring Plan (CMP).
Main responsibilities include:
Supports the Centralized Monitoring Lead (CML) in the development of the fitfor 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 peerreview 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
23 years SAS experience preferred including macro language
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 problemsolving 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
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
Required Experience:
IC
Employment Type
Full-Time
