Teams at Novotech

Support and maintain paper and electronic Trial Master Files (TMF) for assigned studies, perform comprehensive QC reviews, mentor/train junior DMAs, prepare reports, ensure TMF inspection readiness, support audits/closeout, and run TMF-related processes and documentation according to ICH GCP and SOPs.

Design, build, validate and maintain clinical trial databases using Medidata Rave, Veeva Vault EDC, and Viedoc. Develop and annotate CRFs to CDISC/CDASH/SDTM standards, configure edit checks, derivations and custom functions, integrate external vendor data, perform testing/UAT and CSV activities, produce reconciliation and review reports, and collaborate with cross-functional teams to ensure data quality and regulatory compliance.

Lead and manage delivery of finance-related projects and migrations using standardized PM methodologies. Oversee planning, resourcing, risk and benefits realization, stakeholder engagement, data migration, system configuration, vendor management, governance, and adoption across global teams.