Victoria Wells Schneiderman, Mba Email & Phone Number

New York, Ny, Us

Lawrence Township, Nj, Us

New York, Ny, Us

-Owner of Rave eConsent product -Define business requirements, establish acceptance criteria, and work closely with UX and Engineering to build out meaningful enhancements and features for Medidata's Rave eConsent-Collaborate with stakeholders to understand new requirements and enhancements, and create patient-centric solutions -Outline scenarios, create real world use cases, and workflows to design solutions supporting real business objectives.-Management of a configuration service designed to increase efficiency in eConsent builds, resulting in decreased timelines for eConsent study and site set-up.-Review, prioritize, and maintain Agile team backlog, including user stories for upcoming sprints, tech debt, and bugs. -Work with project management and engineering management to understand priorities and dependencies.

New York, Ny, Us

-SME on eConsent product and services-Successful implementation of eConsent and virtual trial in 20+ clinical trials, including data integration both internally and externally-Comprehensive understanding of IRB/IEC requirements for the approval of eConsent and virtual trials globally. -Project management and implementation of eConsent for both adult and pediatric clinical trials, from study start up to study closure across multiple projects simultaneously-Create and develop project specific requirements specifications-Establish and coordinate client team members for workshops and meetings that identify eConsent and virtual trials software requirements-Communicate UAT parameters and provide product demonstrations to internal and external product stakeholders, as requested-Analysis of IRB-specific informed consent forms to determine eConsent and virtual trial application development requirements-Cross-functional engagement with engineers and developers for the development of application software per study-Interface regularly with Product team to discuss eConsent enhancements, roadmap, client needs, and best design practices for end user experience-Produce timely documentation and reports to support client requirements-Work with the Quality Management team and Technology team to ensure that all Enroll products and services are designed and validated for regulatory compliance-Draft eConsent process documentation; implementation of process documentation-Coordinate device shipment to clinical trial sites-Manage project specific production releases, site activations, and user account activation

Davis, California, Us

-Participates in cross-functional team in the design and development of software products and services using an Agile process-Attend stand-up meeting with Client Services team-Host product demonstrations to internal and external product stakeholders, as requested-Establish and coordinate client team members for workshops and meetings that identify software requirements-Produce timely documentation and reports to support client requirements-Work with the Quality Management team and Technology team to ensure that all Mytrus products and services are designed and validated for regulatory compliance, with supporting documentation and artifacts produced as specified by the Mytrus SDLC SOP

-Collaborate with principal investigators to assist in study design & development and manage up to 15 ongoing studies simultaneously, from start up to completion.-Interface with industry pharmaceutical company sponsors & NIH to facilitate clinical trial opportunities.-Thorough knowledge of FDA regulations, ICH guidelines, and GCP -Draft & prepare required federal, state, & institutional documents for submission to Institutional Review Board for study approval. -Interview, select and lead teams of undergraduate student volunteers for various projects including investigator-initiated research studies. Attend investigator meetings and conferences with principal investigators.-Recruited over 100 patients for various clinical trials within the department, bringing in over $150,000. -Negotiated advertising fees from $5,000 down to $2,000 with Clear Channel & CBS networks for billboard & radio advertising of recruiting studies.-Represented UC Davis Dermatology at National Psoriasis Foundation’s annual Walk for Psoriasis event.

-Administered psychological tests-Observed and recorded research studies, scored psychological tests, and input data into computer system-Data entry and data management-Recruited and screened potential subjects for research study participation-Performed literature searches using PubMed database. SSPS Data entry.

Master Of Business Administration (Mba)

B.S., Human Development