The Software Devl Manager is responsible for independently delivering clinical data programming, transformation, and review solutions in support of global clinical trials
Job Summary
The Software Devl Manager is responsible for independently delivering clinical data programming, transformation, and review solutions in support of global clinical trials.
Key responsibilities include developing and maintaining Python and R programs for data cleaning, transformation, review, and analysis, as well as supporting downstream activities and database lock.
The role requires close collaboration with Data Managers, Clinical Programmers, Statisticians, and Medical Reviewers, and emphasizes compliance with ICH-GCP, 21 CFR Part 11, and CDISC standards.
Matching Summary
The Software Devl Manager is responsible for independently delivering clinical data programming, transformation, and review solutions in support of global clinical trials.
Skills & Requirements
Must-have
Python and R programming
Clinical data standards (CDISC SDTM)
SQL skills
Clinical trial data experience
Regulated clinical data environments
Nice-to-have
Process automation and innovation
Cross-functional collaboration
Minimal supervision
Inspection-ready deliverables
Key Requirements
Bachelor's or Master's degree
Experience with clinical data systems (EDC / CDB / CDMS)
Experience with version control systems (e.g., Git)