Danielle Wall Email & Phone Number

Jersey City, Nj, Us

Jersey City, Nj, Us

Global operational lead for Phase 3 study in rare disease. Study site selection / feasibility. CRO selection and budget negotiation. EDC & IRT set up / UAT. EDiary design / patient app build. Global lead for Phase 2a trial in Scleroderma / Rare Disease with sites in the US, Canada, and EU/UK.

Foster City, Ca, Us

Study Lead for Phase 2 NASH Study that will support Gilead's Ph3 NASH program. Managed all vendors including CRO, Covance, and Central IRB. Lead cross-functional team meetings and was responsible for making team decisions, building timelines, and creating strategy for achieving study milestones. Lead all study start-up activities including writing the protocol/ICFs/study documents, selecting sites/feasibility, and setting up contracts/SOWs with sites and vendors. Most recently, developed a study-specific strategy to mitigate the risks of the COVID-19 pandemic while continuing to progress towards reaching enrollment and data milestones.Japan and Asia Pacific region lead for Phase 3 primary sclerosing cholangitis study (rare liver disease). Responsible for all region-specific decisions, site/CRO oversight and management, and budget/financials. eCOA/ePRO vendor lead for Phase 2 chronic spontaneous urticaria (hives) study. Managed ePRO vendor selection and setup. Designed app with ePRO vendor. Authored ePRO sections of protocol, FDA review documents, and garnered approval from FDA for Gilead's first app-based, BYOD study using eCOA as primary endpoint. Oversaw licensing, translation, and IRB approval of questionnaires in 5 different languages for study regions (US, Canada, Spain, Germany, Poland). Oversaw timelines and mitigated risks to on-time launch. Also was IXRS vendor lead for study - responsible for IXRS design, setup, and specifications review, UAT. Achieved early system launch. Wearables/Data Lead and Assessments (ePRO/eCOA) Lead for Gilead's Decentralized Trial Design Project within the Tech and Innovation Group. Responsible for developing a business guide for digital / direct-to-patient clinical trials, which will serve as the framework for future decentralized clinical trials at Gilead. Authored sections on wearables and eCOA.

Foster City, Ca, Us

Bracket (IWRS) Lead, Canada Region Lead, Data Management Lead, and Wearable Devices Lead on large global Phase 2 NASH trial (400 subjects) that contained Gilead's 1st ever Wearable Sub-Study. Study Lead for smaller Ph2 NASH study that will support Gilead's Ph.3 NASH program. Lead all aspects of the trial including managing the CRO and all vendors, leading cross-functional study team meetings, and authoring protocol, SOWs, and all study documents. Experience with study start-up through closeout. Accountable for all aspects of the trial. Supported collaboration between Gilead and Path AI by integrating liver biopsy data from Covance into Path AI systems in order to facilitate a machine learning algorithm that can analyze and categorize pathology data.

Foster City, Ca, Us

Provided study support for two phase 2 NASH Studies within the Liver Disease Dept. Trial Master File (TMF) Vendor lead. Responsible for tracking enrollment milestones, financial accountability including invoice/automated payment review, regulatory/systems support, and meeting minutes. Saved >$50k by recognizing errors in the automatic payment structure. NASH product lead for the Investigator Brochure Initiative, a working group with the goal of improving the investigator brochure/product risk language review, approval, and distribution process.

Palo Alto, Ca, Us

Clinical Research Coordinator within the psychiatry department of Stanford University. Coordinated multiple industry and NIH protocols investigating the etiology of pediatric mood disorders as part of Stanford's Pediatric Emotion and Resilience Lab (PEARL).

San Francisco, Ca, Us

Content marketing role consisted of writing content for the company blog, creating copy for the Halo website, developing design briefs for new web pages, composing press releases, spearheading email marketing campaigns, creating content and design for product user manuals, and writing articles about the company for major tech publications like TechCrunch and QZ. CRA role consisted of designing and conducting original clinical research trials using the Halo Sport device.

Cambridge, Ma, Us

Tested differential DNA repair mechanisms in mouse embryonic stem cells (mES) versus mES cells converted into cerebellar neurons in vitro.Techniques: cell culture, fluorescence microscopy, RT-PCR

Paris, Fr

Created structural mutants of the pentameric ligand-gated ion channel GLIC, a bacterial homologue of nicotinic acetylcholine receptors, and used fluorescence to characterize functionally relevant regions of the protein. Techniques: directed mutagenesis, 24-liter protein production, cell culture, immunofluorescent labeling, fluorescence microcopy, and fluoro-spectrometry

Cambridge, Ma, Us

Worked on Radcliffe Fellow Mei Zhen’s project in the Samuel Lab at Harvard's Center for Brain Science to create a Scanning Electron Microscopy (SEM) reconstruction of the C. elegans nervous system throughout different developmental stages. Completed a successful integration of the voltage-sensitive fluorescent gene ArcLight into temperature-sensitive (AIB) neurons of C. elegans.

Worked on a project testing infants’ ability to subconsciously compute average size using the looking-time paradigm. A second project involved looking at the role of executive function in reaction time and accuracy of a memory task for 5 year olds.

Tampa, Fl, Us

RA in Moffitt’s Summer Program for the Advancement of Research and Knowledge. Successfully cloned a new virus that would more effectively over-express a tumor-suppressor protein (PRDM1) involved in inducing apoptosis of mantle cell lymphoma cells. Techniques: PCR/qRT-PCR, gel electrophoresis, plasmid digest and restriction analysis, bacterial transformation, plasmid purification, recombination, viral transfection and transduction, cell culture, and Western Blot.

Neurobiology, Neurobiology And Behavior

Education record