Teams at Veristat

Provides project-related financial and analytical support to Project Managers and serves as a liaison between functional groups and Finance. Responsibilities include project analysis, portfolio financial management, forecasting, revenue recognition, backlog and invoicing analysis, decision-support reporting, and managing confidential financial data while meeting client and corporate deadlines.

Leads clinical data management activities from study start-up through database lock for complex clinical research projects. Oversees data quality, documentation, project teams, and multiple studies; leads and mentors clinical data managers; ensures compliance with SOPs, sponsor requirements, ICH GCP, and applicable regulations. Provides technical leadership, training, consulting, project planning, and data management expertise across internal and external teams.

Leads strategic and operational regulatory consulting for pharmaceutical and biotech clients from early development through NDA/BLA. Prepares IND, NDA/BLA, orphan drug designation, fast-track, and FDA advice-request documentation; advises clients and internal teams; serves as a client and Health Authority liaison; leads FDA interactions; and supports business development and marketing. Provides technical and supervisory leadership while applying knowledge of ICH GCP, clinical trials, regulatory requirements, and CRO-pharmaceutical relationships.