• Provide strategic guidance on bid defense and budget formulation, directly contributing to optimized budgets and increased win rates on major contracts.• Seamlessly fill interim roles, including project manager, lead data manager, and principal database programmer, maintaining project continuity and mitigating risks associated with resource shortages.• Interview 25+ candidates and assist with the selection of management team members to fill 2 roles to date.• Facilitated 6 training sessions for the director of data management and the functional service provider (FSP) manager to ensure seamless company operations.

• Hired as the company’s first US director of data management to establish a data management presence in the US and promoted to senior director in 2020, recognizing leadership in building the department, expanding the team, and advancing strategic initiatives.• Established the US data management team and grew it to 25+ professionals, strategically recruiting and developing talent to meet expanding project demands.• Oversaw budget and directed internal and external data management operations, including resource management, client relations, standards development, and cross-functional support, streamlining department workflows.• Managed 7 key clients, supervised 50+ studies, and facilitated 3 successful NDA submissions to the FDA.• Oversaw critical project milestones, providing hands-on solutions and strategic oversight to ensure successful project execution within time and resource constraints.• Assumed various roles, including project manager, lead data manager, and database programmer, to maintain project timelines, working on eCRF, edit check specifications, EDC database builds, UAT, and database locks.• Presented in bid defense meetings and supported business development initiatives, effectively aligning data management capabilities with client needs to secure new business.• Revamped the data management hiring strategy and led targeted training efforts, strengthening the team with skills-based development and structured project support for junior staff.• Co-developed a performance evaluation system for the U.S. data management division with the general manager, promoting a high-performance culture that rewarded efficiency and supported work-life balance.• Led the implementation of a set of tools using Monday.com to monitor workloads, manage resource assignments, and track project status, enhancing departmental efficiency and workload transparency.

• Managed EDC database programming and data management activities for study start-up and was promoted from senior data scientist to senior manager in 2018, recognizing high performance in project execution.• Independently handled all aspects of Rave database builds as a single person functional group, including updates and migrations.• Authored the SOP for Medidata RTSM setup, establishing a streamlined process for trial randomization and supply management that improved process consistency.• Configured and maintained Medidata RTMS database.• Developed SAS programs for central lab data reconciliations.

• Led a project team of 7 EDC designers for the company’s largest client, overseeing weekly resource estimates, timelines, and quality control for EDC database builds, including RAVE eCRFs, edit checks, and custom functions.• Resolved complex technical issues, including core configuration of Rave URLs and custom function programming while managing task assignments, tracking progress, and providing guidance to the project team.• Acted as a technical liaison, advising 2 clients and internal teams on complex change orders, providing feasibility and risk assessments, and delivering tailored solutions for database design and migration.• Led a team to complete 12 change controls within 30 days, addressing urgent safety directive updates to meet client requirements under tight deadlines.• Oversaw Rave data integration with IVRS/IWRS and ePRO systems, collaborating with external vendors on specifications, XML data transfers, and troubleshooting to ensure seamless data flow.• Assessed custom report requests and developed Rave reports using BOXI, enabling data-driven insights and enhancing reporting capabilities for client projects.

Provided specialized services in CDISC SDTM data conversion for legacy clinical trials. Created and maintained comprehensive documentation for content mapping and CRF casebook annotation and built a CDISC-compliant lab dictionary. Developed a web-based software suite for medical review and remote site monitoring, which adopted CDISC SDTM-based data architecture and enabled real-time generation of patient profiles and safety reports, allowing the trial management team to analyze clinical operation data and monitor site performance remotely.

Led the global project team for the high-profile Rivaroxaban compound, leading all aspects of EDC database builds in both Rave and Inform, including eCRF creation, edit checks, and custom functions. Developed standard SDTM data conversion programs using Oracle SQL and PL/SQL and trained the team in their use. Spearheaded the successful delivery of Johnson & Johnson’s first Inform trial, RAVE trial, and CDISC-compliant trial, setting the foundation for future EDC database development. Served as a technical leader in EDC technology evaluation and vendor selection. Developed reports and listings, summarizing data cleaning status and pinpointing issues for correction. Oversaw CRO data management activities, ensuring timely and high-quality deliveries. Collaborated with lab, PK, PD vendors on data transfer specifications, and performed quality control on data transfer files.

Reviewed data management plans, suggested improvements, and programmed edit checks using Oracle PL/SQL in ClinTrial. Managed data transfers. Identified performance issues with ClinTrial and reported bugs to the vendor. Tuned complex SQL code, which resulted in a significant reduction in running time for edit checks on a mega trial involving 10,000+ patients.

Performed data review and query generation, ensuring the integrity and quality of clinical data. Defined and programmed edit checks in the Trial Data Review (TDR) application. Trained data managers in edit check testing and EDC software evaluation. Performed SQL code tuning that greatly reduced the running time of edit checks.