Haojun (Mike) Feng Email & Phone Number

Denver, Co, Us

Boulder, Co, Us

Dallas, Texas, Us

• Directly manage a team of 4 data managers, overseeing 20+ risk medical device clinical trials through all phases (pilot, feasibility, pivotal, and post-market), including experience leading on clinical trials submitted to the FDA for 510(k) clearance• Manage external vendors and oversee $400,000 worth of vendor contracts • Doubled the size of the team by interviewing, recruiting, and hiring over 10+ data managers while ensuring low staff-turnover by building a culture of excellence• Author standard operating procedures (SOP) and developed work instructions for the clinical data management team• Collaborate with engineering teams to develop data architecture pipelines, standardize access controls across data warehouses, and automate data quality surveillance tools in order to achieve world class data quality standards• Implemented 3rd party software intended for regulated clinical trials and lead computerized system validations to ensure 21 CFR Part 11 compliance• Advised engineering and product team on electronic data capture (EDC) features, design, and user interface while collaborating with legal and compliance teams to establish GCP and HIPAA compliant data management processes• Lead data management activities for the Baseline COVID-19 Testing Program, establishing scalable and automated processes to manage access for 300+ testing sites and 2000+ users to screen over 1 million users• Navigated unexpected complexities with time-sensitive projects which arose due to the COVID pandemic by identifying issues with scope and state of data, and proposing analytical and technical solutions• Cooperated with external partners to advancing clinical research methods through innovative tools and technologies by serving as the external interface to Verily’s internal engineering teams

• Support clinical trial manager with study start-up through close-out activities (e.g. IRB submissions, study tracking, and document management), ensuring study timelines are on pace with company milestones• Collaborate with cross-functional disciplines (e.g. data management, biostatistics, engineering, etc.) to develop study materials such as protocols, informed consent forms (ICFs), case report forms (CRFs), etc.• Manage the clinical documents of Trial Master File (TMF) and ensuring regulatory compliance• Analyze data for health coaches and product manager to determine the next steps in the product design• Train internal site staff on study protocols and company procedures, manage internal research studies, and collaborate with company leads to develop standard operating procedures for the research center

Palo Alto, Ca, Us

• Oversaw all clinical research operations (enrollment, data collection, patient needs, etc.) and mentored 3 staff members• Developed electronic database to capture the study progress of 350+ participants, overhauled data management process to reduce study queries by 95%, and pioneered study protocols utilized by 15 sites• Spearhead conferences to educate over 100 attendees on an autoimmune disease, connecting patients and caregivers with local providers• Designed research projects, drafted grants applications, and managed institutional review board (IRB) applications• Reviewed literature and presented on novel ideas in Multiple Sclerosis to clinicians and researchers

San Francisco, California, Us

• Implemented study investigating device monitoring sleep apnea device in 20 surgical oncology patients• Devised standard operating procedures for nurses, ensuring accurate timely and accurate data collection• Steered bi-weekly meetings to communicate on study progress and develop project schedules• Performed data analyses and presented study findings in the department research conference

• Coordinated communications between providers, patients, and investigators to study the interventions for breast cancer, hypertension, and obesity in studies ranging from 20 to 300 participants• Trained and supervised 3 volunteers, ensuring data of 300+ participants were scored accurately• Implemented study visits, drafted study documents, and designed 2 study databases

• Guided preschool aged children through an educational software and ensured that they stayed on task

Us

• Maintained a high level of customer satisfaction by bagging customers’ orders and assisting customers• Organized the store by returning merchandise to store shelves, retrieving carts, cleaning spills, and removing damaged products from the shelves

Bachelor'S Degree, Psychology

Psychology