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.