Sr. Manager, Business System Lead
Core
Business System Owner and Lead responsible for the roadmap, delivery, and functional ownership of trial delivery systems (process and listing systems) in the life sciences sector.
Role type
Senior Manager, Business System Lead
Builds
Trial delivery systems (process and listing systems) for drug development and clinical trials
Domain
Life Sciences / Biopharma / Clinical Trial Operations
Required skills
Strategic roadmap definition, stakeholder management, budget management, GxP validation, 21 CFR part 11 compliance, inspection readiness, vendor landscape analysis, cross-functional collaboration
Preferred skills
Veeva EDC, Veeva Clinical eTMF/CTMS, process owner network systems, software implementation in biopharma, GCP inspection settings
Technologies
Veeva EDC, Veeva Clinical eTMF/CTMS, process owner network systems
Responsibilities
Drive roadmap prioritization and delivery for trial delivery systems; Serve as Business System Owner (BSO) for assigned systems; Develop and maintain functional and cross-functional stakeholder relationships; Interpret functional priorities and partner with R&D leadership; Support inspection readiness and represent system expertise; Contribute to annual budget planning and forecasting; Serve as Subject Matter Expert (SME) and internal consultant
Seniority
Senior Manager, hands-on leadership