• Managing direct end-to-end clinical trial management activities, domestically and globally, by leading and taking ownership in all aspects of study planning, start-up and oversight of study execution • Leading clinical operation execution of complex protocols within a matrix environment (Project Management, Safety, Outsourcing and Vendor Alliance Management, Data Management, Statistics, Clinical Supplies, Safety, etc.)• Developing new work streams, SOPs, study templates, tracking tools and dashboards to support optimal clinical operations performance • Managing vendor selection process, negotiating contracts and budgets with sites and vendors to present to executive study team • Mentoring and managing the growth and development of Clinical Trial Managers (CTM)

•Managed and collaborated on complex CAR-T protocols within a matrix environment (Data Management, Safety, Outsourcing, Vendor Alliance Management, etc.) •Planned, executed, and led study meetings to report on all aspects of clinical trial progress to senior leadership•Collaborated in the preparation and review of study-related documents (e.g., Study Operations Plan, Monitoring Plan, Informed Consent, tools/worksheets and other study-specific documents or manuals)•Developed and oversaw comprehensive study timelines and metrics to ensure consistency with corporate strategy

•Coordinated/Executed all operational aspects of CAR-T clinical studies, including study start-up, patient enrollment, follow up, and study closure activities. •Coordinated with contract vendors and Clinical Research Organizations to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.•Performed co-monitoring and oversight visits at participating sites, CROs, clinical labs, etc., to ensure compliance with the Investigational Plan and appropriate regulations, guidelines, and policies.

•Exhibited mastery of Clinical Trials Manager position to effectively conduct, complete or train personnel as needed in less senior Clinical Operations positions•Independently managed multiple phase 1-3 US and global studies and assured process consistency between studies•Identify and efficiently oversaw multiple vendors for multiple studies (laboratories, contract research organizations etc.)•Managed direct reports and assisted with hiring,mid-year and annual reviews, promotions/demotions and termination as applicable•Provided regular updates to senior management on the implementation and progress of all clinical development projects•Ensured that all studies are conducted in compliance with GCP, relevant SOP's & regulatory requirements

•Actively provided regular updates to senior clinical operations management on the implementation and progress of all clinical development projects•Managed multiple phase 1-3 US and global studies and assured process consistency between studies•Created study documents for multiple studies (budgets, timelines, template forms) while managing the clinical trial master file to ensure consistency •Communicated daily with institution based clinical investigators/research staff (patient related safety, budget, data, monitoring staff, payments) •Efficiently oversaw multiple vendors for multiple studies (laboratories, contract research organizations etc.) •Responsible for meeting enrollment, budget and timeline goals for multiple studies

•Documented and conducted site initiation, routine monitoring and close out visits, reviewed files, forms and filings to ensure alignment with SOPs, study guidelines and GCP best practices. •Identified and recruited site investigators, coordinated the movement and delivery of trial materials, samples, tests and forms, including investigational medicinal product, protocols, SOPs, CRFs, project documents, forms and support tools. •Acted as primary contact for any questions or issues that arise from investigational sites to ensure all site related issues are followed until resolved. •Participated and presented at study team, kickoff and investigator meetings, monitored site budget adherence and acted as primary contact to sponsors for all monitoring related issues.

•Conducted and facilitated specific start-up activities such as Site Regulatory Package (SRP) collection, Clinical Site Agreement (CSA) & Informed Consent Form (ICF) negotiation.•Supported site management activities to ensure timely site initiation and enrollment.•Performed all clinical monitoring tasks and/or remote visits, applying expertise and independent judgment for designated projects in accordance with relevant regulations, SOPs, and study specific guidelines while ensuring patient safety and data integrity.•Managed and supported site activities remotely, resolving site issues, and ensuring timely/high quality data entry at a site level

•Recruited, screened and scheduled subjects for participation in GI oncology clinical trials who may benefit from translational therapy. •Fostered interdisciplinary collaboration by attending investigator meetings, tumor boards and conferences to develop investigator-initiated clinical trials. •Facilitated business development by meeting key leaders in biotechnology industries to bridge the gap between academia and industry to fulfill unmet needs in medicine. •Assisted regulatory department with IRB submissions and continuing reviews in keeping with GCP guidelines and FDA regulations. •Processed, shipped and handled biological substances according to GCP guidelines and IATA.

•Assured all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. •Scheduled and participate in monitoring visits and participate in multidisciplinary program meetings. •Assisted multidisciplinary team in research activities, including staff protocol training, patient assignment, and intercommunication with clinical staff and trial sponsors. •Designed systems for coordinating, compiling and submitting data; designing workflow processes and participated in quality assurance measures.

-Performed research evaluations involving virology, fish dissections, PCR and ELISA.-Wrote and edited manuscripts for PhD candidates on bacterial kidney disease, diporeia virus, and VHS. -Purchased beneficial equipment to improve efficiency while retaining grant expenditures.-Assisted in statewide workshops to educate governmental agencies on fish health and housing.-Collaborated with the Caspian Sea Environmental Programme in Kazakhstan to assess fish ecology.