Sr. Manager, Business System Lead
Core
Partners with Data, Digital & Technology partners to drive roadmap prioritization and delivery for successful operationalization of trial delivery systems (process, listings systems) and serves as Business System Owner (BSO) for systems used in trial delivery.
Role type
Senior Manager, Business System Lead
Builds
Trial delivery systems (process listing systems) for drug development and clinical trials
Domain
Life sciences / Biopharma / Clinical Trial Delivery
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Functional/business ownership of trial support systems, Stakeholder relationship management, System roadmap development, Software Development Lifecycle (SDLC) support, Inspection readiness and regulatory compliance (GxP, 21 CFR part 11), Budget planning and forecasting, Subject Matter Expert (SME) consulting
Preferred skills
Veeva EDC or Veeva Clinical eTMF/CTMS experience, Process or process owner network systems experience, Software implementation within biopharma organizations, GCP inspection settings experience
Technologies
Veeva EDC, Veeva Clinical eTMF, CTMS, GDO systems
Responsibilities
Develop and maintain functional and cross-functional stakeholder relationships, Interpret functional priorities and partner in system roadmap execution, Collaborate with R&D DD&T and Trial Delivery leadership, Serve as BSO to support Software Development Lifecycle, Contribute to inspection readiness and representation of system expertise, Support Sr. Director in building processes and infrastructure, Stay informed on vendor and innovation landscape, Contribute to annual budget planning and forecasting, Support value realization for system investments, Serve as SME and internal consultant to management
Seniority
Senior, hands-on IC with strategic oversight
