Nancy Yang, Ms, Ccrp Email & Phone Number

San Francisco Bay Area

Product Development Global Biomarker Operations: Oncology Provides operational expertise and guidance to cross-functional study management teams across biomarker lifecycle.Develops, maintains and effectively executes project plans to meet the biomarker analysis timelines, budget, risk and quality deliverables. Manages day-to-day operational monitoring of third party vendors to ensure delivery against contracted scope of work, Defines, negotiates, implements and communicates scope of biomarker projects.Identifies, communicates and mitigates project risks. Creates and maintains project schedules, defining activities, sequence, dependencies, duration and associated resource requirements.Manages quality trade-offs.Plans and manages internal and external project communications, ensuring effective exchange of project information and deliverables.Track and manage project budgets, POs and invoices.Identifies and continuously contributes to areas of best practice and process improvements and innovation, supporting effective delivery of solutions.Ensures study adherence to ICH/GCP and SOPs.

Developed and analyzed clinical trial research data sets for publication

 Coordinated six interventional and two observational Phase I-III industry and PI sponsored clinical trials (focused on developing therapeutics for lymphatic and venous disorders).  Screened, consented, and enrolled patients, conducted study visits, educated at-risk patient population of disease risk Ensured CRF and source document regulatory compliance with FDA, GCP, ICH and SOP regulations Oversaw subject recruitment and study enrollment goals. Determined effective strategies for promoting, recruiting and retaining participants in long-term clinical trials. Developed and designed database systems and CRFs to organize, monitor, and assured quality of all clinical measurements Led and managed the design and construction of the International Lymphatic Disease Patient Registry and Tissue Bank for Stanford School of Medicine. Overhauled more than 2000 survey questions serving as a foundation for a 20 year study. Conserved $20,000 of departmental budget.  Independently extracted, interpreted, and analyzed data to contribute to IRB submissions, presentations and literature publications from 2013-2015. Discovered primary variable demonstrating drug success in patient population; reduced study timeline by 33% Directed team meetings in brainstorming study approaches, and identifying project targets, measurements, and schedules in collaboration with multiple organizations; oversaw ongoing negotiation as contract agreements changed and technical requests were updated. Mentored and trained new staff Determined, recommended, and implemented improvements to policies and processes; defined best practices Lead for all human tissue specimen collection, processing, and storage needs; developed new isolation protocols to improve DNA/RNA/protein yield in subsequent analysis assays.

Conducted weekly lab and discussion sessions, introduced students to molecular biology techniques and concepts

Protein sciences focus on HPLC, ELISA immunoassay, phage panning

M.S., Biological Chemistry

Activities and Societies: Graduate student researcher, Asian Pacific Health Corps (APHC)

Bachelor’S Degree, Molecular And Cell Biology: Cell And Developmental Biology

Activities and Societies: Undergraduate Research Apprenticeship Program (URAP), Research assistant in Nutritional Sciences and Toxicology.