Automotive Embedded Software Engineer (C/C++ | Autosar)

Expleo; Valladolid; À distance; EUR 67 000 - 94 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Monitoring Analyst (Cluepoints) with strong SAS programming and data management experience. The role involves setup, programming and refreshes of the CM platform, collaboration with clinical teams, and documentation in the CMP/eTMF.

Excellent communication and ability to work autonomously are required. Eligible for remote work with international project exposure; knowledge of regulatory requirements and data management practices is essential.

Qualifications

• Experience in pharmaceutical R&D or related field, preferably Centralized Monitoring, data management or biostatistics.
• 2-3 years SAS experience including macro language.
• Knowledge/experience working on Cluepoints.
• Ability to work autonomously with stakeholders.
• Understanding of basic statistical analysis concepts.

Responsabilités

• Maintain CM support process and ensure requests follow procedures.
• Use service assurance tools to diagnose problems and create reports.
• Set up/Program QTL, KRI, and Data Quality Assessments per CMP.
• Refresh CM platform per schedule and document updates in eTMF.
• Review study protocol and data sources to support CM activities.
• Peer-review CM platform setup by colleagues.

Connaissances

SAS programming

Strong communication

Statistical concepts

Data management

Cluepoints

English proficiency

Formation

Bachelor's degree

Outils

Cluepoints

Relational databases

EDC Systems

eTMF

Description du poste

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

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 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. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

EEO Minorities/Females/Protected Veterans/Disabled

NTT DATA

NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long‑term success. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start‑up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure, and connectivity. We are also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo.

Equal Opportunity Employer. NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category.

Key responsibilities

• Maintains the support process and ensures that requests for support are handled according to the procedures.
• Uses service assurance software and tools to investigate and diagnose problems, collects performance statistics and creates reports, working with users, other staff and suppliers as appropriate.
• Identifies and resolves problems following agreed procedures.
• Carries out agreed maintenance tasks.
• Ensures usage of knowledge articles in incident diagnosis and resolution and assist with updating as and when required.
• Performs defined tasks to monitor service delivery against service level agreements and maintains records of relevant information.