Shirley Vu Email & Phone Number

United States

United States

Hayward, Ca, Us

Menlo Park, Ca, Us

• Lead CDM for REFLECTION, a multi-center, prospective, non-interventional, RWE study.• Design, develop, test, and maintain clinical studies in GRAIL EDC, ensuring protocol-driven data collection and compliance.• Cultivate and maintain strong relationships with site partners, including Vincere Cancer Center, Providence, Carolina Blood Cancer Care Associates, and Veterans Affairs, providing comprehensive EDC training and support throughout the study lifecycle.• Spearhead data cleaning efforts, collaborating with the team to ensure data cleanliness for analysis and overall project needs.• Program study listings, reports, and dashboards, delivering actionable insights to study teams and leadership using R.• Develop Tableau workflows for clinical study dashboards, enhancing data visualization accessibility to study teams.

Menlo Park, Ca, Us

• Support start up (including eCRF design, UAT, site onboarding) of REFLECTION, a real world evidence (RWE) study hosted in the company's internally developed GRAIL EDC system• Contribute to data cleaning processes using Medrio, ensuring high-quality data for analysis.• Implement study dashboard metrics using R/Rmd to provide stakeholders with real-time insights.• Provide comprehensive training to the CDM team on in-house EDC features and workflows.

Us

Foster City, Ca, Us

• Led and supported multiple Phast III studies, serving as clinical data management point of contact for study management team throughout study timepoints, including analysis timepoints, closeout, and CRF archiving.• Collaborated extensively with cross-functional teams, including Clinical and Statistical Programming, Clinical Operations, Biostatistics, Clinical Research, Safety, Regulatory, and Project Management, to meet deliverables and timelines by ensuring secure acquisition, integration, and quality of clinical data.• Drove process improvements through insightful recommendations.• Ensured accurate translation of study protocol into Medidata Rave by designing, developing, and testing eCRFs and edit checks.

Foster City, Ca, Us

Austin, Texas, Us

• Ensured clarity, consistency, and completeness of patient, test requisition, and ordering clinic data, and timely issue of non-invasive prenatal testing reports to clinics via laboratory information management system (LIMS).• Collaborated cross-functionally with customer support specialists, genetic counselors, statisticians, and engineers to track and resolve missing, discrepant, or erroneous data issues and queries.• Participated in the development and implementation of data management and reporting SOPs to optimize efficiency and ensure data integrity.

San Francisco, California, Us

• Assess DNA availability and preparation for next-generation sequencing and genome-wide association studies by screening through the subject sample database. • Extract, quantify, and normalize human DNA from frozen whole blood, saliva, and buccal samples. • Randomize and plate study samples using Biomek 3000 liquid handling robot.

• Administrative and clinical duties in the front and back office.• Translated (Vietnamese-English) and medically scribed in EMR. • Screened CPAP/BiPAP users and obtained compliance reports. Performed MMSE, Epworth sleepiness scale, and MOCA exams. Completed physical therapy and DME forms. • Submitted procedure authorizations using ICD9 and CPT coding, transmitted lab referrals/medication/diagnostic imaging orders, and scheduled appointments for follow ups, sleep studies, EMG, and EEG procedures.

Fremont, California, Us

• Tutor high school students in biology up to the AP level. • Liaise between the company, parents, and students to establish the schedule and direction of tutoring to achieve common goals and guarantee success and satisfaction.

• Assessed the effect of various microbiological agents, polyphenols, phytochemicals, and oxidative stress on keratinocyte motility.• Performed migration assays, western blots, and protein, RNA and DNA extraction. Compiled, analyzed, and created visualizations of data generated.• Managed human keratinocyte and sebocyte cell lines, prepared lab reagents and media, and maintained a detailed and organized laboratory notebook.

• Assisted in the Cardio Thoracic Step-down Unit, Emergency Department, and Child Life department.• Provided company and emotional support for patients and their families while maintaining an inviting, clean, and safe environment. • Transported patients and their families upon discharge.• Led musical recreation and art projects with patients beside and in the children's play room.• Fed and supervised infants bedside.• Interpreted and organized patients' EKG strips.

South San Francisco, California, Us

• Wrote, reviewed, and executed risk assessments associated with the environmental control program including differential pressure, manufacturing monitoring frequency, microbial sampling, and exterior and ancillary equipment cleaning.• Compiled and analyzed excursion data to understand impact of construction, maintenance, and facility and utility systems shutdown/restart. Revised SOPs to enhance company program.• Facilitated weekly multi-departmental meetings to discuss emerging issues and address trends in manufacturing environmental control.

Foster City, Ca, Us

•Managed transgenic mouse colonies including weaning, ear punching, tissue sampling and genotyping. •Isolated DNA from frozen rat and mouse tissues and conducted qPcr and data analysis. •Conducted western blots, protein isolation, and bacterial culture. •Discussed data analysis and project direction with senior scientist and research team at weekly lab meetings.

Master Of Science (Ms), Data Science

Bachelor’S Degree, Neurobiology, Physiology & Behavior Major; Psychology Minor