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.

Supports investigator payment processing and grant development for clinical research studies. Reviews protocols, contracts, visit data, and payment reports; builds site-specific subject visit tracking templates in CTMS; processes and reconciles investigator payments; prepares budgets and estimates; addresses fair market value questions; manages system access and vendor issues; and collaborates with project managers, clinical operations, investigators, and clients while following SOPs and quality requirements.