About this role
Clinical Data Engineer CDP & DP
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
- Set up study-level data collection elements as well as program triggers, derivations and data cleaning checks/listings/reports.
- Set up 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 and 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
External Partners
- 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.
- 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).
- 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.
- Strong organizational and time management skills, with the ability to work independently and collaboratively in a global environment.
- 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 - 06/10 Reference Code: 885371 Division: Pharmaceuticals Location: Spain : Cataluña : Barcelona Functional Area: Information Technology Position Grade: VS 1.1 Employment Type: Regular Work Time: Full Time Contact Us Address Telephone E-Mail
Av. Baix Llobregat, 3, 08970 Sant Joan Despí,
Barcelona, Espanya
+34 93 495 69 99 [email protected] (mailto:[email protected])