Enterprise Growth Manager – Health Tech (Hybrid, Barcelona)

GCO Ventures; Barcelona; Remote; EUR 80,000 - 116,000; Full time

Job summary

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) for a remote role. You will support the Centralized Monitoring process, perform CM platform setup, programming and refreshes per CMP, and collaborate with sponsor clients on deliveries.

Ideal candidates have 3+ years in pharma R&D or data management, 2–3 years SAS (including macros), knowledge of Cluepoints, and strong communication with global stakeholders; English fluency is required.

Qualifications

• At least 3 years relevant experience in 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 autonomously and engage with stakeholders to execute activities related to study level centralized monitoring process.
• Excellent command of English (verbal and written).

Responsibilities

• Supports the Centralized Monitoring Lead (CML) in developing the CM strategy by identifying the relevant CM elements for the study (QTL, KRI, data visualizations, and Data Quality Assessments).
• Setup/Program QTL, KRI and Data Quality Assessments according to the CMP.
• Refresh the Centralized Monitoring Platform at predefined frequency to enable signal identification.
• Generate and maintain the CM platform specifications document and file in eTMF.
• Understand the study protocol and data sources; transfer specs and data structure.
• Execute and document peer-review of CM platform setup done by CMA colleagues.

Skills

SAS programming

Cluepoints experience

Data management

Tools

SAS macro language

Relational databases

EDC systems

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).

• 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. ... (company culture and EEO statements omitted for brevity)