C#.Net Engineer

Alten Spain; Burgos; A distancia; EUR 79.000 - 105.000; Jornada completa

Descripción de la vacante

IQVIA seeks a Clinical Monitoring Analyst (Cluepoints) for a remote role, supporting Centralized Monitoring with strong SAS programming skills. You will help design CM strategies, program QTL/KRI/DQA, and refresh CM platforms aligned with CMP, while engaging with clients to deliver study-level monitoring.

You will review protocols, understand data sources, and maintain confidentiality while collaborating with cross‑functional teams in an international setting. Fluency in English required.

Formación

• At least 3 years relevant 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 and engage with stakeholders to execute study-level monitoring.
• Understand basic statistical concepts and interpret outcomes.
• Maintain confidentiality of data during interactions at all levels.
• Experience with relational databases and EDC systems.
• Excellent verbal and written English.
• Advanced knowledge of GCP and GCDMP.

Responsabilidades

• Support Centralized Monitoring Lead in developing CM strategy and implement QTL, KRI, data visualizations, and DQA per CMP.
• Setup/Program QTL, KRI, and DQA according to CMP.
• Refresh CM platform regularly to enable signal detection.
• Produce CM platform specifications document and file in eTMF.
• Review study protocol to understand data sources and transfer specs.
• Document peer-review of CM platform setups by colleagues.
• Communicate with stakeholders to ensure robust CM delivery.

Conocimientos

SAS

Cluepoints

CML/CM lead collaboration

Data management

Biostatistics

English communication

Regulatory knowledge (GCP/CDEA)

Autonomous working

Herramientas

SAS Macro language

Cluepoints platform

EDC systems

Relational databases

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).

Main responsibilities include:

• 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. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. 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. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled

Make an impact with NTT DATA

Join a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion - it's a place where you can grow, belong and thrive.

Your day at NTT DATA

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.
• Analyses service records against agreed service levels regularly to identify actions required to maintain or improve levels of service, and initiates or reports these actions.
• Prioritizes and diagnoses incidents according to agreed procedures.
• Investigates causes of incidents and seeks resolution.
• Escalates unresolved incidents and follows up until incident is resolved.
• Provides service recovery, following resolution of incidents.
• Documents and closes resolved incidents according to agreed procedures.
• Maintains secure, accurate, complete, and current configuration on configuration items (CIs).
• Applies tools, techniques and processes to track, log and correct information related to CIs, ensuring protection of assets and components from unauthorized change, diversion, and inappropriate use.
• Remotely investigates and identifies root cause of incidents and assist with the implementation of agreed remedies and preventative measures.
• Maintains knowledge of specific specialisms, provides detailed advice regarding their application.
• Ensures efficient and comprehensive resolution of incidents, including ensuring that repairs are carried out by coordinating product requests, working with other team members.
• Provides continuous feedback to clients and affected parties and update all systems, portals and ticketing tools as prescribed by standard operating procedures.
• Identifies problems and errors prior to or when they occur.
• Logs all such incidents in a timely manner with the required level of detail with all the necessary.
• Cooperates with all stakeholders including client IT environments, vendors, carriers and colleagues to expedite diagnosis of errors and problems and to identify a resolution.

Knowledge, Skills and Attributes:

• Ability to communicate and work across different cultures and social groups.
• Ability to plan activities and projects well in advance and takes into account possible changing circumstances.
• Ability to maintain a positive outlook at work.
• Ability to work well in a pressurized environment.
• Ability to work hard and put in longer hours when it is necessary.
• Ability to apply active listening techniques such