Teams at Novotech

Programs, designs, tests, validates, and maintains clinical trial databases and data review listings. Performs data reconciliation and external data loads, coordinates data transfer specifications with vendors, annotates CRFs according to CDISC standards, supports system validation, and ensures compliance with SOPs, GCDMP, and ICH-GCP. Collaborates with project teams and supports Project Leads on clinical trial data management activities.

Manages paper and electronic Trial Master Files for clinical research projects, ensuring documents are received, scanned, uploaded, tracked, filed, and maintained according to ICH GCP, regulatory requirements, and SOPs. Performs comprehensive QC reviews, prepares reports and checklists, resolves findings, supports audits and inspections, and prepares files for study closeout. Mentors new team members and contributes to clinical operations processes and SOP development.

Leads clinical data programming and database development across multiple clinical research projects. Responsibilities include advanced edit-check programming, database configuration, migrations, validation fixes, deployments, technical troubleshooting, vendor coordination, quality reviews, requirements documentation, and risk analysis. The role also mentors programmers, supports SOP and best-practice development, and contributes to process improvement, quality control, and governance.