Especialista En Sistemas Y Cloud (Azure/Aws) – Hybrid Madrid

Randstad Digital España; Madrid; Remote; EUR 55,000 - 75,000; Full time

Job summary

NTT DATA is seeking a Clinical Monitoring Analyst (Cluepoints) to remotely manage centralized monitoring activities across sponsor projects. You will participate in setup, programming and refreshes of the CM platform in line with the study CMP.

You will need 3+ years in pharma R&D or CM, plus 2-3 years SAS experience (including macro language). Strong communication and data management knowledge are essential for success in this role.

Qualifications

• At least 3 years of pharma R&D or Centralized Monitoring experience.
• 2-3 years SAS experience including macro language.
• Advanced knowledge of GxP, regulatory requirements and data management.
• Excellent English communication and collaboration skills.

Responsibilities

• Support the Centralized Monitoring Lead in CM strategy development.
• Setup/Program QTL, KRI and Data Quality Assessments per CMP.
• Refresh the CM platform at defined frequencies to identify signals.
• Generate and maintain CM platform specifications and document in eTMF.
• Understand study protocols, data sources and transfer specs.
• Peer-review CM platform setups performed by colleagues.

Skills

SAS

Cluepoints

Communication

Data interpretation

Tools

SAS

Cluepoints

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

• 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 its 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

EEO Minorities/Females/Protected Veterans/Disabled

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