Winnie Chang Email & Phone Number

Oakland, Ca, Us

South San Francisco, California, Us

-Spearheaded transfer and build of in-house Veeva eTMF after CRO transition including month-long TMF upload, 6 month-long in-depth TMF QC of over 8000 documents, and sponsor-requested TMF audits-Collaborated on CAPAs to address observations from TMF audits, generate NTFs for gaps in TMF-Conducted and tracked site outreach, coordinated finalization of CDA between sponsor/CRO/site, monitored the completion of feasibility questionnaires, and assisted with creation of site selection letters-Engaged in and provided feedback on Medidata RAVE EDC UAT testing scripts-Researched ongoing competitive studies and design recruitment materials to help boost study enrollment-Managed Veeva Vault user accesses for internal and external study team members and ensure required trainings are complete-Developed draft of File Management Plan, review protocol amendments and ICFs, file documents in SharePoint, BOX, and TMF-Facilitated the collection of signed training forms for internal and external SOPs from cross-functional team-Participated on panel interviews for CRA, Sr. CRA, AD, CTM candidates

Foster City, Ca, Us

-Maintained clinical information and training of Clinical Operations personnel in the clinical trials management system (GILDA)-Prepared and provided assistance in development of study-specific information utilizing databases, spreadsheets, and other tools-Interacted with other departments to plan and facilitate meeting logistics, agendas, and minutes-Actively supported study startup for global phase 3 study including CDA review, CDA requests, and Site Selection-Drafted and finalized key study plans and manuals that act as guidance for conduct of clinical trial

San Diego, Ca, Us

-Supported the Clinical Operations team with ongoing conduct of studies and collaborate with CRO, vendors, and cross-functional counterparts-Coordinated and scheduled of study team meeting, vendor meetings, and other large group meetings; recorded, distributed, and filed study team meeting minutes and materials-Routed study documents to the trial master file according to study requirements; coordinated receipt of final TMFs, participated in auditing the TMF based on file specifications and inventory-Managed and maintained study documents or trackers, conducted review and approval of essential documents to support site activation.

San Diego, Ca, Us

San Diego, Ca, Us

Clinical Operations: -Reported to the Head of Program Management & Strategic Initiatives. Cross-functional coordination of NPT520-34 Program (IND submission through initiation and conduct of Phase 1). -Experienced different phases of clinical trial management -Prepared clinical trial metrics and study newsletters to maintain management appraised of study progress and performance.Corporate Communications: -Managed Corporate Website Content -Coordinated Press Releases -Coordinated Social Media

La Jolla, Ca, Us

-Directly mentored three project groups on their cognitive design project

Sacramento, Ca, Us

-Analyzed data from MHSOAC transparency suite to create data-driven research briefs -Developed HTML page with JavaScript embedded Google Charts-based graphics-Advanced knowledge and understanding of Mental Health Services Act programming around the state

La Jolla, Ca, Us

-Lead two discussion sections of 60 students each for which I held office hours-Formulated PowerPoint review slides for exams-Course material include what happens in the brain when something goes wrong (OCD, Alzheimer’s, Parkinson’s, Huntington’s, Addiction, etc.)-Received Departmental Award: Most Effective Instructor’s Assistant

Bachelor Of Science - Bs, Cognitive Science Specialization In Clinical Aspects

Minor, Business