Senior Fp&A Analyst – Corporate Fp&A & Saas

Aris; Madrid; A distancia; EUR 55.000 - 75.000; Jornada completa

Descripción de la vacante

IQVIA is seeking aClinical Monitoring Analyst (Cluepoints) to work remotely on international sponsor projects. The CMA will set up and refresh the centralized monitoring platform, performing programming and data QC for study CMPs while collaborating with clients directly.

Required are advanced SAS programming skills (including macros), experience with Cluepoints, data management and good understanding of regulatory standards. Excellent English communication is essential.

Formación

• Minimum 3 years in pharmaceutical R&D or related field with centralized monitoring, data management or biostatistics.
• 2–3 years SAS experience including macro language.
• Experience with Cluepoints and strong data source understanding.

Responsabilidades

• Set up, program and refresh the centralized monitoring platform per CMP.
• Develop CM strategy elements like QTL, KRI and data visualizations.
• Coordinate with CM Lead and stakeholders to deliver study level CM activities.
• Review protocol and data transfer specs; document CM platform setup.

Conocimientos

SAS programming

Centralized Monitoring

Data management

Biostatistics

Cluepoints

Herramientas

Cluepoints

EDC Systems

Descripción del empleo

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

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