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 Centralised Monitoring process by performing the setup, programming and refresh(es) of the Centralised Monitoring platform, according to the study‑specific Centralised Monitoring Plan (CMP).
Main responsibilities
- Supports the Centralised 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 visualisations and Data Quality Assessments)
- Setup/Program QTL, KRI and Data Quality Assessments according to the study CMP
- Refresh the Centralised Monitoring Platform at predefined frequency to enable signal identification
- Generate and maintain the Centralised 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 centralised 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 centralised 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, organisational 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**
EEO Minorities/Females/Protected Veterans/Disabled