Michael Chang Email & Phone Number

Benicia, Ca, Us

Alameda, California, Us

- Develop and review Blinded Independent Radiology Committee (BIRC) RECIST 1.1 and PCWG3 data checks in collaboration with Lead Biostatistician, Clinical Trial Physician, and Clinical Scientist to validate and accept primary, interim, final, and exploratory endpoints related to PFS event and censoring statuses- Lead and facilitate CDM process improvement initiatives such as SAS migration, study start-up, and EDC and data review standards- Perform exposure, disposition, and PFS and OS efficacy data reviews- Assist in the development of standard CRFs, edit checks, and custom functions for early and late phase oncology clinical trials

Alameda, California, Us

- Performed UAT of data review listings pertaining to RECIST 1.1 endpoint data reviews- Performed End of Radiographic Follow-up surveillance and Case Completion (CCA) to support BIRC data collection and adjudications- Developed Data Transfer Plan (DTP) for the transfer of clinical data to BIRC- Reviewed routine and final BIRC data transfers to support endpoint analysis data acceptance including scan reconciliation between Oracle InForm/RAVE EDC, BIRC Scan Summary Report, and BIRC data transfers- Collaborated with Technical Operations and Clinical Operations for submission and reconciliation of imaging data to BIRC for interim and final analyses- Collaborated and consulted with Medical Monitor, Clinical Science, and Biostatistics for data issues and acceptance

Princeton, New Jersey, Us

- Drafted, updated, and finalized data transfer, image transfer, and external document reconciliation specification documents (DTS, ITS, and EDRS)- Programmed and validated data transfer, image transfer, and custom SAS and SQL programs- Defined and reviewed edit checks for identifying and resolving discrepant data- Created and updated transmittal forms for studies, ensuring consistency with existing standards- Prepared and coordinated the review of test, production, interim, and final transfer outputs- Resolved and addressed sponsor reconciliation reports

Princeton, New Jersey, Us

• Resolved discrepancies identified by sponsor reconciliation reports• Performed quality assurance of Brain MRI Worksheets (BMWs) prior to reporting safety findings• Developed and maintained Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs)• Trained new employees on department procedures, data tracking, and study deliverables• Tested engineering enhancements and system maintenance changes in a user-acceptance testing environment prior to release

Princeton, New Jersey, Us

• Reviewed, processed, tracked, and reported all imaging data received from sites• Coordinated neuroradiologist and third-party quality control assessments• Updated Salesforce contacts from global distribution list trackers• Monitored, investigated, tracked, and resolved data discrepancies resulting from logistical edit checks and clinical data management• Reported issues found with study systems (i.e. study database, reading analysis system) using issue tracking system

Princeton, New Jersey, Us

• Served as the primary operations contact for the clinical sites and Project Manager• Planned and coordinated site start-up activities including, but not limited to, preparation and reproduction of study materials, facilitation of pre-trial questionnaires to evaluate scanner acceptance, scheduling of logistical and technical trainings with site personnel, requesting phantom test data, and authorization of imaging facilities for acquiring patient scans • Generated queries (data clarifications, incomplete package notifications, repeat request notifications) for resolution with clinical sites• Managed site communications, generated site and patient reports and queries, and verified reports prior to distribution to clinical sites and sponsors• Read, understood, and adhered to organizational Standard Operating Procedures (SOPs) and Study Specific Procedures (SSPs)

• Operated various skin instruments (VISIA-CR, Intellistudio, HiScope, Novameter, Chromameter, D-Squame, Tewameter, Cutometer, Laser Doppler, Sebumeter, Replicas, and Ultrasound) to validate claims and efficacy of cosmetics products• Developed image analysis algorithms for imaging instruments• Quality control and quality assurance of participant information in a ClinicalConductor database• Prepared and maintained study documents (Informed Consent Form, Release Forms, Study Sheets, and FAQs) according to clients’ and industry standards• Analyzed numerical and image data statistical significance of claims and efficacy testing• Scheduled study visits and issued payments on participants’ ClinCards through ClinicalConductor database

Philadelphia, Pennsylvania, Us

- Maintained paper Trial Master Files for over ten ongoing clinical research studies (sponsor and investigator-initiated)- Monitored IRB and primary source documents for quality control, reported any discrepancies to supervisor, and corrected mistakes as needed- Created and modified case report forms to ensure efficient data collection- Developed Microsoft Excel spreadsheets for automated scoring of assessments (POMS and PDQ-39) conducted with clinical patients with Parkinson's Disease

Philadelphia, Pennsylvania, Us

• Conducted psychological measures (MMSE, CDR, and BDI) and with clinical patients with Alzheimer’s Disease and their family members• Worked closely with Principal Investigator to quantitatively and qualitatively assess PET scans to determine a novel radioactive tracer’s effectiveness in diagnosing Alzheimer’s Disease• Conducted initial phone screening with potential research subjects and medical record review to determine eligibility• Coordinated with Thomas Jefferson University’s Outpatient Imaging Center to schedule visits according to the sponsor’s protocol

Philadelphia, Pa, Us

- Assisted with ongoing driving simulator studies at The Center for Injury Research and Prevention- Analyzed videos of subjects by recording behavioral observations and identifying trends- Designed road tiles for development of urban, suburban, and rural driving simulator courses