Clinical Data Engineer CDP & DP

Bayer; Barcelona; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

Bayer Spain is seeking a data-driven professional to drive the setup and maintenance of clinical data collection instruments, ingestion, and integration across study sources. You will support data quality and pipelines for risk monitoring and analytics in collaboration with global teams.

Responsibilities include defining data requirements, building end-to-end data flows, and enabling traceability for CROs and partners.

Formación

• Bachelor's or Master's degree in Natural Sciences, Life Sciences, Statistics, Computer Science, Data Science or related fields.
• At least 3 years in a scientific, data-driven position, preferably with experience in clinical data management.
• Experience in programming languages (C#, SQL, SAS, Python, R) and clinical information systems.
• Familiarity with big data technologies, cloud infrastructure (AWS, Azure, GCP), and data integration tools (Databricks).
• Understanding of global regulatory requirements and CDISC standards.
• Strong organizational and time management skills, with ability to work independently in a global environment.
• Strong communication skills in English.

Responsabilidades

• Analyze clinical protocol to create requirements and technical specifications for data collection, data ingestion, quality measures, data integration and transformation for all study sources ensuring end-to-end focus.
• Setup study level data collection elements, program triggers, derivations and data cleaning checks/listings/reports; perform data ingestion for CRO and vendor data; develop and validate programs for study setup, conduct and closeout within the Clinical Data Environment/Lakehouse.
• Provide clinical study data to business users; ensure smooth data flow and traceability; address data flow issues.
• Support project timelines for clinical studies; evaluate issues; assess impact of changes; implement and test updates; ensure study setup docs are ready for inspections and audits.
• Contribute as a subject matter expert for function level processes, systems/tools.

Conocimientos

Programming languages

SQL

SAS

Python

R

Clinical systems

Databricks

AWS

Azure

GCP

Communication in English

Educación

Bachelor's or Master's degree in Natural Sciences, Life Sciences, Statistics, Computer Science, Data Science or related fields

Herramientas

Databricks

Descripción del empleo

Main Purpose
Drives the setup and maintenance of clinical data collection instrument(s), data ingestion and integration capabilities from all study data sources (sites and vendors – labs, IRT, ePRO, digital devices, etc.), based on the Clinical Study Protocol and Medical Standards in collaboration with the study team and other internal as well as external stakeholders.
Main Purpose
Drives the setup and maintenance of clinical data collection instrument(s), data ingestion and integration capabilities from all study data sources (sites and vendors – labs, IRT, ePRO, digital devices, etc.), based on the Clinical Study Protocol and Medical Standards in collaboration with the study team and other internal as well as external stakeholders.
Implements programs/listings for data quality checks as well as builds optimized data flow pipelines to enable risk monitoring processes (CDM, Med Review, Site Management, Med Coding) and statistical analysis/reporting.
Key Tasks & Responsibilities

• Requirements & Specification: Analyze clinical protocol to create requirements and technical specifications for data collection, data ingestion, quality measures, data integration and transformation for all study sources ensuring complete end-to-end focus.
• Task Delivery: Setup study level data collection elements as well as program triggers, derivations and data cleaning checks/listings/reports. Setup and perform data ingestion activities for CRO and vendor data, data exchanges with internal and external partner systems, as per agreed data transfer specifications. Develop and validate programs for study setup, conduct and closeout activities within the Clinical Data Environment/Lakehouse. Provide clinical study data to business users, ensuring smooth data flow and traceability while addressing any data flow issues.
• Project Management: Plan, prioritize, and communicate timelines for clinical studies. Support these studies throughout their lifecycle by evaluating issues, assessing the impact of changes, and implementing and testing updates. Ensure all study setup documentation is completed on time and comply with relevant SOPs to be ready for inspections and audits.
• Best Practices: Contribute as a subject matter expert for function level processes, systems/tools.
  

Scope

• Global
  

Key Work Relations (Internal/External)

• Clinical Study Team Members:Study Managers, Study Data Managers, Medical Experts, Statisticians, Statistical Programmers, Medical Writing, Drug Safety, Medical Coding)
• Technology Related Partners:IT System Owners, DSA&I Process Managers/Clinical Data Engineers/Project Managers/Scrum Masters
• Enabling Functions: Standards Management, Vendor Management, Procurement, Customer Centricity, etc.
• External vendors and partner companies
  

Skills & Qualifications

• Education: Bachelor's or Master's degree in Natural Sciences, Life Sciences, Statistics, Computer Science, Data Science or related fields. Equivalent degrees or certifications may be accepted.
• Experience: At least 3 years in a scientific, data-driven position, preferably with experience working in the clinical data management discipline.
• Technology & Programming: In-depth experience in programming languages (e.g., C#, SQL, SAS, Python, R) and clinical information systems following software development processes.
• Familiarity with big data technologies, cloud infrastructure (AWS, Azure, GCP), and data integration tools (e.g., Databricks).
• Industry Practices - Preferred: Understanding of global regulatory requirements and guidelines (e.g., ICH, GCP, HIPAA) related to clinical investigations and data collection. Knowledge of CDISC clinical data standards.
• Self Organization: Strong organizational and time management skills, with the ability to work independently and collaboratively in a global environment.
• Communication & Collaboration: Strong communication skills in English, both written and verbal. Proven ability to collaborate with internal and external stakeholders demonstrating decision making capabilities.
  

Application Period: 21/09 - 06/10Reference Code: 885371
Division: PharmaceuticalsLocation: Spain : Cataluña : Barcelona
Functional Area: Information TechnologyPosition Grade: VS 1.1
Employment Type: RegularWork Time: Full Time
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