Teams at Novotech

Lead and deliver transformation initiatives across the CRO, managing project plans, resources, budgets, governance, risk, benefits realization, stakeholder engagement, change management, testing/data migration, vendor coordination, and tracking using standardized PM methodologies to ensure timely adoption and improved operational efficiency.

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.