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.
Accountability:
- 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
- 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.
Job Description
- Experience with EDC build/data management or EDC extraction/configuration; strong 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.
Veramed is a B Corp accredited company which means that we use the power of business to build a more inclusive and sustainable economy meeting the highest verified standards of social and environmental performance, transparency, and accountability.
As an organisation that has people at the heart of it, Veramed is committed to creating a diverse environment and is proud to be an equal opportunities employer. We foster a working culture where employees have integrity, honesty and respect for one another without regard to race, national origin, religion, gender identity or expression, sexual orientation or disability. All qualified applicants will receive equal consideration for employment.
Originally posted on Himalayas