Bounthavy Chanthabandith
San Diego,CA
Summary
Results-oriented Clinical Research Professional with hands-on and leadership experience in the full cycle data management process. Recognized team-player and self-starter whose strengths include project management, assessing quality, device accountability, and sample reconciliation.
Overview
21
21
years of professional experience
Work History
Director, Clinical Data Management
TRACON Pharmaceuticals, Inc.
01.2022 - Current
- Administer GxP data management software on the front end
- Communicate with commercial software solution vendor(s) regarding identified bugs and requested software improvements and manage (i.e
- Track and document) the resulting software fixes through validation in accordance with Tracon SOPs
- Participate in community GxP software review meetings and provide Tracon feedback/requests
- Oversee the training of site staff, monitors, and clinical operation staff in the use of software applications that support data management (EDC, randomization software, etc.)
- Manage the use of data standards for data collection and reporting
- Oversee the cleaning of clinical trial data, both for internal use and publication as well as standards compliant reporting for submission to health regulatory agencies
- Liaise with IT and vendors for back-end server and GxP application support and other infrastructure needs
- Develop SOPs and job aides relating to all aspects of data management
- Train DM staff in the development of all data cleaning, snapshot and finalization deliverables and ensure that each staff member is qualified to perform job responsibilities
- Create Data Validation Plan (DVP) template and review and approve study specific DVPs
- Participate in creating systems and processes surrounding data quality for all programs
- Control and maintain metadata libraries for CRFs and SDTM reporting
- Oversee the creation and maintenance of studies to enforce consistency in the metadata libraries
- Assist in validation efforts for select software and reporting tools.
Associate Director, Clinical Data Management
TRACON Pharmaceuticals, Inc.
01.2020 - 01.2022
- Review data and generate queries according to the data validation specification (DVS)
- Maintain documentation relating to clinical data management including maintaining the data management and biostatistics portions of the Trial Master File
- Write and maintain DVS
- Interface with and train site personnel, monitors and clinical operations staff to provide support related to data management (including EDC system issue resolution)
- Author and assist in streamlining clinical data management procedures to create effective practices
- Set up studies in EDC using appropriate data standards, report data from those studies in human readable format for use by the clinical study team, and transform those data into SDTM compliant datasets ahead of submission to regulatory authorities in compliance with 21 CFR Part 11
- Write and edit checks in XML and data listings in SQL or R or other languages
- Write code, participate in peer code review, validate code, and maintain code repositories in support of publications (clinical study reports, posters, papers, investigator brochures, annual reports, etc.) in compliance with 21 CRF Part 11
- Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
- Correspond with and oversee data management vendors
- Perform tasks in compliance with TRACON SOPs and applicable regulatory requirements
- Assist in validation and testing of software for GxP or supporting systems.
Senior Clinical Data Manager
TRACON Pharmaceuticals, Inc.
01.2018 - 01.2020
- Review data and generate queries according to the data validation specification (DVS)
- Maintain documentation relating to clinical data management including maintaining the data management and biostatistics portions of the Trial Master File
- Write and maintain DVS
- Interface with and train site personnel, monitors and clinical operations staff to provide support related to data management (including EDC system issue resolution)
- Author and assist in streamlining clinical data management procedures to create effective practices
- Set up studies in EDC using appropriate data standards, report data from those studies in human readable format for use by the clinical study team, and transform those data into SDTM compliant datasets ahead of submission to regulatory authorities in compliance with 21 CFR Part 11
- Write and edit checks in XML and data listings in SQL or R or other languages
- Write code, participate in peer code review, validate code, and maintain code repositories in support of publications (clinical study reports, posters, papers, investigator brochures, annual reports, etc.) in compliance with 21 CRF Part 11
- Coordinate with pharmacovigilance to review and generate queries related to serious adverse events
- Correspond with and oversee data management vendors
- Perform tasks in compliance with TRACON SOPs and applicable regulatory requirements
- Assist in validation and testing of software for GxP or supporting systems.
Clinical Data Manager
Astute Medical, Inc.
01.2011 - 01.2017
- Performed Data Management responsibilities to the highest degree from study start-up, protocol development, database build, QC audits, to database-lock
- Collaborated with EDC vendor to develop database for a multi-center international clinical trial
- Completed UAT, data validation checks, implementation of database with custom functions, and interfaced with EDC vendor to resolve issues
- Met and negotiated with EDC Database vendors to find alternative, more cost-effective database solutions
- In the absence of the Associate Director, managed a team of three contract data managers and coordinated study closure activities simultaneously for three related studies, culminating in a successful PMA submission
- Streamlined CRF design by applying observations from previous clinical trials
- Coordinated activities required for database lock one month ahead of schedule, and facilitated clinical database audit that resulted in a 99% error free rate
- Developed standard data management procedures and guidelines such as Clinical Data Review, UAT Testing, Sample Reconciliation and Destruction
- Managed discovery pilot studies, both US and EU, encompassing study start-up, contract management, data management, and sample bank management
- Maintained cordial and productive relationships with clinical sites through routine communication regarding study updates, data management, and sample shipments
- Managed sample reconciliation to ensure samples were collected, shipped, and received properly according to protocol requirements
- Collaborated in editing and formatting of new protocols, informed consent, CRF design, generation of study materials, CSRs, Statistical Analysis Plans, Data Management Plans, and site specific regulatory document review and collection
- Supervised data entry, verification, query generation, filing of clinical data, and ensure compliance of SOPs and GCP guidelines
- Developed reports of clinical trial results for senior management used to secure funding from venture capital firms
- Led quarterly meetings for Sample Use and Storage, per Clinical Trial Agreements, Informed Consents, and CRADA specifications
- Represented Clinical Affairs in Sunshine Act reporting, ensuring payments made to physicians and institutions are accurately reported per FDA regulations
- Due to a reduction of staff, took on responsibilities in Medical Affairs, such as approving publications for dissemination, and fulfilling Unsolicited Requests from prospective customers
- Contributed to the positive moral of the company through active participation in company events, including organizing potlucks, sports activities, and the annual Holiday party.
Clinical Data Specialist I/II
Boston Scientific, Inc. (formerly CryoCor, Inc.)
01.2004 - 01.2009
- Assisted with planning and organization of data management for US and International clinical studies
- Managed the flow of clinical data consisting of Case Report Form tracking, data-entry, verification, audits and database lock
- Liaised with core lab to ensure quality and timeliness of data transfers
- Prepared data and reports of SAEs for DSMB review
- Performed medication and adverse event coding activities
- Managed device accountability to ensure medical devices were properly used, stored, and returned/destroyed
- Participated in the creation and editing of new protocols, informed consent, CRF design, generation of study materials, and site specific regulatory document review and collection
- Took on the responsibility of Concomitant Medication and Adverse Event coding (using MedDRA) and reporting when human resources were reduced
- Ensured all data discrepancies, protocol deviations, and serious adverse events are reported to the Clinical Monitor or Project Manager
- Assisted in the automation of a CRF tracking system by integrating it into a database schema, which enabled all members of Clinical Affairs to track status of outstanding data
- Took initiative to learn database capabilities without training and expanded the functionality of the database for improved data storage and efficiency in reporting results
- Participated in FDA audit of the first PMA submission which resulted in no corrective actions or issues for Data Management
- Produced data listings and reports used to present and defend clinical results at FDA Panel meeting resulting in a positive outcome
- Recipient of a 'No I in Team' award
- Created CRFs, regulatory binders and other documents for the clinical sites, create files for the CRFs, and provided support while other members of the department are traveling
- Logged in CRFs as they are retrieved from the clinical sites, performed data entry, and generated data clarification forms for sites on data questions or clarification
- Assisted in the maintenance of clinical files, both hardcopy and electronic
- Assisted the clinical sites and field operations by processing supply order forms and device requests
- Assisted with the day-to-day operations of Clinical Affairs Dept
- By providing clerical support as necessary
- Maintained the bibliography and library of pertinent publications.
Education
Major: Civil Engineering (did not complete) -
University of California, Berkeley
Berkeley, CAScripps Ranch High School
San Diego, CASkills
- Veeva-certified Study Designer
- Proficient in Microsoft Office, Crystal Reports, Adobe Designer, and Relational Databases
- Competence in Basic SAS, SQL Server Management, CDASH, and MedDRA coding
Timeline
Director, Clinical Data Management
TRACON Pharmaceuticals, Inc.
01.2022 - Current
Associate Director, Clinical Data Management
TRACON Pharmaceuticals, Inc.
01.2020 - 01.2022
Senior Clinical Data Manager
TRACON Pharmaceuticals, Inc.
01.2018 - 01.2020
Clinical Data Manager
Astute Medical, Inc.
01.2011 - 01.2017
Clinical Data Specialist I/II
Boston Scientific, Inc. (formerly CryoCor, Inc.)
01.2004 - 01.2009
Major: Civil Engineering (did not complete) -
University of California, Berkeley
Scripps Ranch High School
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