Brian Mai Email & Phone Number

Proficient in imaging protocol deviation surveillance oversight, with experience in radiographic imaging in a clinical environment and knowledge of RECIST 1.1.Assists in coordinating and supporting imaging site start-up activities with Clinical Operations and Imaging Core Lab(s).Monitors cross-study technical and operational issues and manages escalated issues to resolution, identifying potential and current issue trends for trend analysis.Communicates complex technical issues to non-technical stakeholders and provides regular updates to internal stakeholders.Applies Data Protection Act to all subject data and ensures subject confidentiality is maintained at all times.Possesses strong organization and communication skills, with excellent attention to detail and orientation toward meticulous work, and is proficient in Excel, Word, PowerPoint

Newark, California, United States

Provide support to Clinical Project Managers in the management and coordination of clinical research projectsDraft project documents and review and edit project presentationsParticipate in project meetings, conference calls, and training callsRead and understand project protocol documentsAct as a liaison with cross-functional team members to ensure timely completion of all study deliverablesMonitor internal data flow to ensure completion of tasks within agreed-upon timeframesMaintain, review, and communicate project progress to clients and stakeholdersVerify protocol imaging requirements are met and queries are appropriately identifiedServe as acting Project Manager in the absence of the assigned Project ManagerMentor, guide, and support the Operations team and provide feedback to Operations Manager for performance appraisalsEnsure adherence to project timelines as they relate to therapeutic processes

Newark, California, United States

Newark, California, United States

Coordinate site and operational activities for assigned studiesAssist in study start-up phase by preparing and reproducing study materials and following up with outstanding documentations from clinical sitesSchedule logistical and technical trainings with site personnelReview, process, track, and monitor all study-related data received from sites and investigate and complete logistical edit checksManage site communications and generate site and patient reports and queriesReport issues found with study systems and perform day-to-day IQC activitiesManage Baseline, Interim and End of Study IQC data submissions, track and report progress to study teams and ensure timelines are metAssist Project Managers with project administration by planning and coordinating site start-up activities, reading and understanding project protocol documents, and participating in project meetings, conference calls, and training callsMaintain client satisfaction by responding to inquiries in a professional, courteous and timely mannerMaintain quality service and departmental standards by reading, understanding and adhering to organizational SOPs, establishing and enforcing departmental standards, and participating in the modification of company SOPs related to the therapeutic teamMaintain technical and industry knowledge by attending and participating in applicable company-sponsored training

Newark, California, United States

United States

Master'S Degree, Medical Product Development Management

Bachelor Of Science - Bs, Business Management Information Systems

High School Diploma