Senior Clinical Research Scientist
Served as scientific lead for company’s GI oncology portfolio, including pancreatic, hepatocellular and gastric cancers. Performed and provided input to wide range of study start-up / close-out activities: Protocol development, medical monitoring planning, ICF, site selection, eCRF build, SIV, risk management planning, and data cleaning. Led regional team of 5 CRSs; developed operational strategies to achieve organizational goals and improved business processes. Mentored new hires and conducted annual performance evaluation.• Co-led 2 PhIII trials of Tumor-Treating Fields in patients with locally advanced pancreatic cancer (PANOVA-3) and brain mets (METIS); drove cross-functional and global collaborations, successfully meeting recruitment goals• Devised strategic engagement plans targeting medical / radiation oncologists and surgeons, significantly shortening enrollment window and improving screening efficiency across 30+ academic and community sites in North America and Asia• Collaborated with internal and external stakeholders to promptly revolve site queries, including responses to IRBs; conducted thorough medical and safety monitoring, ensuring high data integrity and strict compliance with regulatory standards• Assessed and led study progress reporting to Swissmedic; addressed queries from FDA related to past safety reports, resulting in all submissions being accepted without revision• Analyzed protocol deviation trends and implemented targeted remedial training with site staff, resulting in significantly improved compliance and reduced deviation rates• Co-led data cleaning initiatives for PANOVA-3 using EDC tools such as RAVE; meticulously reviewed over 200 patient profiles, identifying and revolving discrepancies to ensure accuracy and reliability of clinical trial data• Contributed to preparation of study reports by optimizing presentation of TLFs; developed pipeline portfolio content to strengthen partnerships with investigators and collaborators