Nastasha C.

Clinical Data Risk Analyst

May 2021 - Present • 5 yrs

● Primary author of inspection critical RBQM documentation, including Central Monitoring Plans, Data Review Plans, QTL Plans, and risk assessment packages for global Phase II–IV trials. ● Lead cross functional documentation development, synthesizing clinical, operational, and data related inputs into clear, consistent, regulatory aligned deliverables. ● Produce scientific summaries, training materials, and slide decks communicating complex clinical risk signals and data insights to sponsors and internal teams. ● Review protocols and clinical documents to identify critical data, define risks, and ensure alignment with ICH GCP and regulatory standards. ● Serve as functional lead managing client communication, expectations, and delivery of high quality analytical and scientific outputs. ● Translate data structures (eCRFs, vendor specifications, transfer agreements) into detailed risk indicator specifications and actionable operational requirements. ● Conduct documentation gap assessments following amendments and system changes, ensuring ongoing accuracy and audit readiness. ● Collaborate with external data vendors (ePRO, eDiary, central labs) to validate data logic, ensure clarity of assumptions, and support consistent interpretation of complex datasets.

Clinical Data Coordinator II

Mar 2020 - May 2021 • 1 yr 2 mos

● Reviewed clinical data for accuracy and completeness using automated and manual checks to uphold data integrity and regulatory compliance. ● Generated and resolved data queries, ensuring clear documentation of decision rationale. ● Organized and maintained audit ready study files, supporting efficient documentation workflows across study teams.