Clinical Study Manager
February 2024 – Present
Talosix, Seattle, WA — Growth-Stage Clinical Technology Company
Clinical Database Architect · Trial Master File Lead · Clinical UX & Product Liaison
- Clinical Operations: Managed Phase I–IV trial execution across Oncology, Investigational Product (IP), and Orthopaedic Registry studies — site activation, CRA training, monitoring, and regulatory documentation across the US and Canada
- Database Architecture: Led eCRF design and build aligned to study protocols; developed data validation scripts, edit check logic, and data review plans for protocol-specific endpoints and adverse event reporting
- TMF Lead/Owner: Owned and maintained the Trial Master File across concurrent studies via Kivo, ensuring inspection-readiness per ICH E6(R2) and the TMF Reference Model
- Product UX: Clinical UX representative for AI-enabled modules — Endpoint Adjudication (Oncology), automated MedDRA/WHODrug coding (IP), and remote trial inventory (multi-site IP accountability)
- Client Management: Primary sponsor and CRO contact for contract coordination, scope alignment, and kick-offs across Oncology, IP, and Registry portfolios
- Quality & Compliance: Developed SOPs, validation plans, and training materials ensuring GCP and 21 CFR Part 11 compliance
- Finance: Managed project financials, site reimbursement verification, and payment tracking