Senior Manager, Clinical Business Systems

Role: Senior Manager, Clinical Business Systems, overseeing GxP-regulated applications supporting Clinical, Quality, Regulatory, and Technical Operations. Responsibilities: manage administration, support, governance, and continuous improvement of validated platforms such as Veeva Vault QMS, RIM, LMS, CTMS, eTMF, Box, and DocuSign; ensure audit readiness, compliance, and system validation; partner with vendors and cross-functional teams; support regulatory inspections and change controls; lead process optimizations and system upgrades. Requirements: Bachelor's in Life Sciences, Computer Science, or related; 8+ years supporting GxP systems within biopharma or biotech; hands-on experience with Veeva Vault, SaaS regulated systems, and knowledge of 21 CFR Part 11, GAMP 5, data integrity (ALCOA+); strong documentation and stakeholder management skills. Preferred: Veeva Vault Administrator certification; experience with clinical technologies like CTMS, eTMF, RBQM; knowledge of Agile, ITIL; prior work in clinical-stage biotech. HighValue: experience supporting regulated enterprise systems, clinical and regulatory workflows, GxP compliance, and vendor management; supporting inspections and audits. WorkSetup: remote with monthly in-office presence in the San Francisco Bay Area; some travel for industry events.