Successful Manager of multiple (Phase I and II) Alzheimer's disease clinicaltrials from initiation through completion, ensuring adherence to protocols,timelines, and budgets.● Collaborated with cross-functional teams, including researchers, physicians,regulatory affairs, and data management, to develop and executecomprehensive trial plans.● Responsible for the site feasibility, selection, and start-up process, ensuringcompliance with Good Clinical Practice (GCP) guidelines and regulatoryrequirements.● Implemented risk mitigation strategies, identifying potential issues and takingproactive measures to ensure trial success.● Actively manage vendors including but not limited to: CRO, imaging,laboratory, eSource and EDC, cognitive testing and IRT system● Accountable for creating, reviewing, circulating, and implementing all studyplans and procedures● Accountable for writing study level Note to Files and Memos● Leads team and/or company calls for study wide updates

Ensure clinical delivery of phase IIIb Alzheimer's Disease study in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).• Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.• Contribute to the development of the project risk mitigation plan and manage clinical risks through the project’s lifecycle.• Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured monitoring and overseeing management of clinical quality issues.• Manage clinical aspects of Project Finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.• Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.• Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.• Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.• Conduct regular team meetings and communicate appropriately to achieve objectives.• Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.

• Oversees Clinical Monitors for sponsor and investigator initiated clinical research• Responsible for managing study site assignments, daily operations, monitor metrics reviews, and data query placements, and closures• Develops and administers ongoing clinical trial education, creating instructional and coaching plans for certified, appropriate staff qualifications and training• Ensures site qualifications, initiations, monitoring, and study closeout visits are conducted in accordance within relevant regulatory regulations.• Monitors and manages ongoing documentation, regulatory, and policy changes and up-dates for clinical monitoring procedures• Serves as primary communications liaison for clinical monitoring and study teams• Recruits, screens, interviews, hires, and supervises clinical monitors• Responsible for all clinical monitor training and ongoing clinical trial education for monitors• Travel to study sites, collecting and analyzing delivery, productivity, and performance metrics of Clinical Monitors

• Leads a study monitoring team on various aspects of trial execution to ensure team follows SOPs, FDA regulations and ICH/GCP guidelines.• Assist in the preparation of instruction manuals, monitor plans, and monitoring tools. • Responsible for managing timelines, materials, and resources. Tracks and reviews that Clinical Site Visits are done on time and in accordance to the Monitoring Manual.• Key contact for protocol, study procedures, and site regulatory questions.• Responsible for the training and task delegation of clinical monitors on the study.

Clinical Monitor/CRA for the Alzheimer's Therapeutic Research Institute (ATRI) of USC.• Serve as a primary contact for over 20 assigned sites and perform clinical monitoring activities, evaluation clinical sites, enhanced site performance and engagement through regular communication and setting clear expectations and provided recommendations that improved process remediation.• On-site clinical monitoring to ensure compliance with GCPs, study protocol and SOPs. • Ensure the integrity of the data submitted on Case Report Forms (CRFs) and other data collection tools, providing input on regulatory documents.• Complete trip reports and serve as contact with sites. Track and account for the review of all CRFs for studies assigned including query resolution and generation.

• Key clinical support role for Phase 4 trials in ultra-rare CNS diseases. • Organized reviews of protocol development, amendments, regulatory submissions, and clinical study reports.• Responsible for TMF transfer, quality check, and reconciliation of two eTMFs.• Effectively manage a vendor of a cognitive assessment company that contributed to pivotal study endpoints. • Support in contact for site start-up activity. Including: completing CDAs, collecting and reviewing regulatory packages, creating and editing Site Initiation Visit (SIV) slides, and performing SIVs.• Submitted key study documents to Central IRBs including initial site submission, protocol amendments, and patient recruitment documents.