Brian Simpson Email & Phone Number

Kirkland, WA, US

Somerset, New Jersey, US

• 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)

Somerset, New Jersey, US

• 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

San Diego, California, US

• 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.

US

• 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

US

• 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

London, Ontario, CA

• 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.
• 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.

Durham, North Carolina, US

• 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.
• 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.

Detroit, MI, US

• 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.