Tara Schweizer Email & Phone Number

•Hired and led an agile team focused on trial delivery technologies and processes. Digital solutions in use/development included: CTMS; QMS; LMS eCOA; (eSource; ePRO; clinical devices); patient portal; and scheduling tools. Enabled 7 trials within 12 months and completed 20 projects worth $58M.•Led the strategy, design, implementation, and validation of protocol specific eSource within Epic and later CRIO- to enable compliant/standardized data collection for decentralized trials at 57+ distinct trial sites. •Guided the establishment of a computer system validation (CSV) infrastructure that included processes, templates, and committees to achieve/maintain 21 CFR Part 11 compliance. •Created and implemented a technical support and iterative training strategy for a network of over 70 sub-investigators that spanned virtual and physical research sites across the US. •Successfully communicated strategy, complex business needs, and related regulatory requirements to adjacent enterprise executives; solutions architects; business analysts; program managers; and developers.•Reconfigured eISF tool and workflows; reduced administrative burden by 10X and enabled centralized management for multi-site trials under multi state principal investigators. •Coached and mentored direct and indirect reports responsible for: implementations; clinical product; data management; access management; user training; system validation; program management; trial conduct; clinical product. •Authored content and tied digital technologies to a library of QMS driven P&Ps; enhanced data integrity, and expedited study startup for phase II-IV trials in immunology, cardiology, neurology, and pulmonology. •Lead enterprise stakeholders to execute end to end IT projects within aligned upon time, scope, and budget to meet business goals and objectives; compliant with SOPs, local regulations, CFR, ICH, and GCP- in the service of Trial Delivery and clinical data management.

AdventHealth Research Institute provides centralized research support to over 400+ Investigators; ~600+ active studies annually; in eleven distinct therapeutic areas.

Conducted world-class research targeting diabetes, obesity, the metabolic origins of cardiovascular disease and aging; specializing in proof-of-concept and mechanism studies through National Institute of Health (NIH), foundations, Biotech and Pharma-funded projects to execute scientifically rigorous and high-quality research studies. In 2021, TRI investigators engaged in 50 active clinical trials and published 63 articles in major journal publications. •Lead Data Management, developed strategy, assigned responsibilities, & managed day-to-day operations to support data collection/transmission.•Oversaw all clinical data management deliverables, including budgets; data management plans; data transfer agreements; data transfer specifications. •Represent the Institute as the lead clinical data manager (CDM) for, site initiation visits (SIV); monitor visits; study start up; and protocol kick off meetings. •Instituted quality assurance (QA) initiatives and Quality Control (QC) measures to ensure data integrity- across all data generating Cores, e.g. imaging, calorimetry, metabolic kitchen, exercise & bioenergetics, and lab. •Active leader on the Quality Committee- and consulted by the Medical Oversight Committee. •Strong working knowledge of regulatory requirements as they relate to trial data and electronic systems including but not limited to FDA, ICH-GCP, and GCDMP (Good Clinical Data Management Practices). •Technical liaison between Enterprise IT and study staff to identify & onboard new tech, e.g., wearables; ECGs; glucometers; accelerometers; and other biomedical devices, (ePRO, eCOA, etc.) •Created source data verification (SDV) strategies and threshold targets with Principal Investigators. •Approved/reviewed data transfer plans for Pharma, including details for Data Transfer Specifications (DTS), employed a working understanding of CDSIC and MedDRA/WHO-DD•Worked with globally based teams to deliver electronic data, e.g., France and China.

• Drafted Clinical Data Management Plans (DMP), for both FDA & NIH Studies. • Collaborated with global KOLs (Key Opinion Leaders, Physician-Scientists) to ensure systematic data collection of scientific and safety endpoints. • Designed electronic source & electronic case report forms (eSource/eCRF); including edit checks and range limits.• Authored SOPs to achieve regulatory compliance for electronic systems and data management practices.• Managed User acceptance testing (UAT) and Unit Testing for various clinical trial applications.• Developed a distributed approach to data entry- across multidisciplinary data generating research Cores. e.g. Medical Imaging, inpatient clinic, metabolic kitchen, calorimetry unit, clinical laboratory, etc.• Created workflow specific application training materials for end-users and trained them on the material.

Orlando, Florida, United States

• Documented scientific endpoints and research objectives for electronic case report form design (eCRF). • Designed electronic Source and Electronic Case Report forms (eSource/eCRF) within Cerner EMR. • Facilitated training and system access. Participated in unit testing. • Coordinated the implementation of vendor/sponsor software and related hardware. • Managed institute’s relationship with enterprise IT. Created strong partnerships via trust and transparency.

Master'S Degree, Health Informatics

Bachelor Of Arts (B.A.), Environmental Science