Teams at Novotech

Manages paper and electronic Trial Master Files for clinical research projects, including document intake, scanning, uploading, tracking, filing, quality control, reporting, audit and inspection readiness, and study closeout. Conducts quarterly or study-plan-based QC reviews, resolves findings and queries, maintains TMF accuracy, and supports clinical operations processes. Mentors new document management associates and contributes to SOP and process development.

Develops and validates clinical data visualizations, dashboards, tables, listings, and reports using SAS and business intelligence tools. Extracts, integrates, transforms, and analyzes clinical and operational data from EDC and other sources to support data review, reconciliation, quality control, and site performance monitoring. Gathers stakeholder requirements, trains users, supports workflow automation, maintains documentation, and ensures compliance with SOPs and regulatory guidelines.

Manages clinical trial data management activities, including database design, validation checks, data cleaning, documentation, client liaison, and compliance with GCDMP, regulatory requirements, and SOPs. Develops Data Management Plans, supports project feasibility and financial tracking, supervises junior staff, contributes to process improvement and business development, and may manage standalone data management or internal IT projects.