Sr. Manager, Trial Support Systems
Core
Business System Owner for trial support systems (process, listings) driving roadmap prioritization, delivery, and operationalization in drug development.
Role type
Senior Manager, Business System Owner (BSO)
Builds
Trial support systems (process listing systems) and trial delivery systems
Domain
Life sciences / Biopharma / Drug development
Deliverable
production ML models | product features | infrastructure
Required skills
Strategic roadmap definition, stakeholder management, budget management, GxP validation, 21 CFR part 11 compliance, inspection readiness, vendor landscape analysis, financial forecasting
Preferred skills
Veeva EDC, Veeva Clinical eTMF/CTMS, process owner network systems, software implementation in biopharma
Technologies
Veeva EDC, Veeva Clinical eTMF/CTMS, process owner network systems
Responsibilities
Partner with Data, Digital & Technology partners to drive roadmap prioritization and delivery; Serve as Business System Owner (BSO) for trial support systems; Develop and maintain functional and cross-functional stakeholder relationships; Interpret functional priorities and partner with leadership in system roadmap execution; Support inspection readiness and represent system expertise for regulatory activities; Contribute to annual budget planning and forecasting; Serve as Subject Matter Expert (SME) and internal consultant to management.
Seniority
Senior Manager, hands-on IC with strategic oversight