Jobs 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.

Design, build, and support full‑stack business applications for a global CRO. Develop front‑ and back‑end components, databases, and APIs; ensure responsiveness, security, testing, QA/UAT, documentation, deployments, vendor escalation, and high customer satisfaction while collaborating across geographies.

Performs clinical trial data entry and validation using CDM systems, supports database testing, query tracking, data reconciliation, reporting, and administrative tasks to ensure data quality per SOPs and ICH-GCP.

Provide day-to-day clinical data management: CRF tracking and filing, data entry, validation, reconciliation, query management, database specification and edit checks, UAT of data entry screens, archiving, metric reporting, mentoring junior staff, supporting CDMs and leading CDA-related activities, and representing the data management team per ICH-GCP, GCDMP and company SOPs.

Support revenue and unit recognition for projects, perform variance analysis and forecasting, reconcile project finances and profitability, manage accrued/deferred revenue, work with PMs, use FinancialForce RM, and mentor junior project finance analysts.

The Investigator Grants Specialist supports project teams in managing investigator payments, processing site budgets, and ensuring timely payments using industry-standard systems. Responsibilities include tracking payments, developing investigator grants, communication with stakeholders, and adherence to Novotech's guidelines.

Support QA lead by planning and conducting internal and external audits (sites, vendors, data, PV, systems), documenting findings, driving CAPAs, reviewing CSV documentation, providing GCP/QA guidance and training, managing vendor evaluations, and maintaining QMS procedures and metrics.

Support finance reporting and payroll administration for the Korea region, including processing and filing severance payments via Samsung Insurance, managing deposit accounts, assisting month-end close and maintaining financial statements, plus ad hoc finance reporting tasks.

The Clinical Document Specialist manages Trial Master File activities, ensuring adherence to SOPs, regulatory guidelines, and driving process improvements, while mentoring new team members.

Design, build, validate, and maintain clinical trial databases using EDC platforms. Develop CRFs, edit checks, custom functions, and external data integrations. Produce data review listings, reconciliation and validation reports. Support CSV, testing (unit, integration, UAT), database amendments, locks, and post-production maintenance while ensuring GCP, SOP, and CDISC compliance. Collaborate with cross-functional teams and external vendors.

Develop and QC SDTM datasets and annotations from eCRFs, protocols and SAPs. Create define.xml, reviewers guides, maintain documentation, follow standards, and collaborate with biostatisticians and programmers.

Lead and scale the Global Shared Services finance function as 2IC to Head of Finance. Own end-to-end AP/AR/Billing/Banking/Expense/Balance Sheet operations, month-end close, reconciliations, payments, controls, and metrics. Drive process transformation, automation, M&A integrations, team leadership, stakeholder management, and deliverable quality across global locations.

Lead clinical systems, reporting and AI/automation initiatives for clinical operations. Manage end-to-end project delivery, stakeholder governance, KPI/reporting definition (Power BI/Excel), and drive adoption, compliance and process improvements across Veeva/Obvio and eClinical platforms.