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: Setup study level data collection elements as well as program triggers derivations and data cleaning checks/listings/ 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: Bachelors or Masters 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.