Anson O. Email & Phone Number

• Provided oversight for CROs and vendors to ensure successful execution of studies across various phases (Phase I-IV). • Supervised CRO data management activities and performed quality control (QC) to ensure adherence to scope, timelines, and accurate documentation of discrepancies and queries. • Led the creation of critical data management documents, such as edit check specifications and electronic case report form (eCRF) design documents, based on protocol requirements. • Evaluated protocols, contributed to database design, and provided expertise on data capture technologies. • Collaborated with database developers to design clinical study databases according to procedures.

• Led the setup, building, and validation of clinical databases, maintaining accurate data capture and seamless data transfer. Set performance goals and conducted regular team reviews to uphold quality standards.• Represented data management in study meetings, providing updates and facilitating discussions to align timelines and goals with overall project objectives. Built and maintained strong relationships with CROs and service providers to ensure data quality and smooth collaboration.• Facilitated internal activities associated with database lock, ensuring closure of queries, reconciliation of Serious Adverse Events (SAEs) and coding, and completion of Principal Investigator sign-off. Collaborated with Business Intelligence team for data analysis.• Negotiated Data Transfer Agreements (DTAs) with external vendors to establish agreements on data frequency, type, and formatting, ensuring successful external data reconciliation during study conduct. • Produced ad hoc reports and conducted batch validation.

• Ensured that all clinical study data captured and maintained by external vendors are incorporated into thestudy database.• Performed medical data encoding as specified in study-specific Coding Plans and protocol.• Performed data review and coordinated the overall management of all data review activities.• Reviewed and processed clinical trial data to ensure the accuracy and consistency of clinical trial database.• Performed data tracking and reviewing for in-house review through use or creation of CRF tracking sheets.• Performed in-house review of CRF for adherence to protocol requirements and project specificrequirements, database cleaning and query resolution, QC and SAE reconciliations.• Documented and addressed any errors, omissions, or inconsistencies found during data review Workedwith project team both internal and external to resolved issues as needed.• Maintained all necessary documentation to support the accuracy of the clinical trial database.• Performed the validation of data fields captured in the database against the CRF when appropriate.• Created dummy data for testing data entry screens and edit checks, Validated data entry screens and editcheck programs.