Objective / Purpose
The Clinical Data Configuration Manager sits within R&D;’s Testing, Innovation, and Data Enablement organization and supports clinical study execution by configuring study-level clinical data extractions, transformations, visualizations, and transfers across multiple data sources in alignment with Data Transfer Agreements and technical specifications. This role partners with internal and external stakeholders (including data engineers) to deliver accurate, high-quality data in required formats and frequencies, contributes to the development and training of transfer standards/SOPs and best practices, and provides quality oversight and team capability support (including mentoring/training others and vendor/FSP oversight as needed) to ensure consistent, on-time delivery.
Accountabilities
- Configure study-level clinical data extraction, transformation, and transfer outputs across multiple data sources per Data Transfer Agreement/specifications.
- Partner closely with internal/external stakeholders (including Data Engineers) to deliver required data formats/frequencies with high quality and on time.
- Support implementation of sponsor-defined data transfer standards and specifications. Provide input to documentation and training materials as requested.
- Perform/coordinate quality review of configuration and deliverables,
including oversight/review of vendor performed work as needed.
- Support team capability by managing and training other team members; complete other assigned duties within timelines.
Education & Competencies (Technical and Behavioral):
- Bachelor’s degree (e.g., CS, statistics/biostatistics, math, biology/health related) plus minimum 5 years relevant experience (or equivalent experience).
- Experience with EDC build/data management or EDC extraction/configuration; solid understanding of clinical data flow (CDMS, vendor devices, CDR).
- Familiarity with data cleaning tools (e.g. Veeva CDB, J Review, Elluminate);
- Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM.
- Data/Integration: XMLs, APIs, MDR (preferred); ETL/ELT experience
- Programming (preferred): One or more SQL, SAS, R or Python; R Shiny/Python app development.
- Tools/ways of working: Microsoft Office
- Independent and collaborative problem-solving; ability to prioritize and work in a fast-paced environment.
- Strong project management skills including: Initiative, deadline management, strong attention to detail, organization, time management; quick learner comfortable with new tech/systems
📌 Clinical Data Configuration Manager (India)
🏢 Veramed
📍 India