• Developed and implemented data management plans (DMPs) and data validation plans (DVPs) for 8+ studies (over 9 years), ensuring comprehensive data management strategies tailored to the unique requirements of medical device trials, and conducted data reviews to ensure alignment with case report forms, protocol, and safety data standards.• Developed custom edit checks in Rave Architect for a global medical device post-market surveillance (PMS) study, reducing data entry errors by 10% and improving data accuracy. Led the technical oversight of service providers performing core data management functions, including CRF/edit check development, user acceptance testing, data cleaning, listings review, and database lock • Automated data validation processes within Medidata Rave to improve data accuracy and reduce manual review time for a Class II ophthalmology device trial, streamlining data management workflows. Led input to clinical data management system enhancements, including performing User Acceptance Testing (UAT), project management, and cross-functional day-to-day delivery. • Utilized SQL programming within SAS to extract, transform, and aggregate clinical database data from a Class III implantable neurostimulator trial, enabling the creation of automated reports for monitoring subject enrollment and protocol adherence. Assessed the quality of statistical programming processes through techniques including good documentation, code review, and testing. • Represented Data Management in internal study team, client, and CRO meetings, negotiating and finalizing Clinical Data Transfer Agreements with external vendors and ensuring adherence to data transfer protocols and organizational standards for a multi-site Class II pulmonary device trial. Led internal, Sponsor, third-party, and investigator meetings. • Monitored and communicated project/program progress to the Sponsor and project team, including the use of project status reports and tracking tools/metrics.

Responsible for overseeing day-to-day data management activities from study start-up through final database lock, including, but not limited to:- Creation and maintenance of the Data Management Plan- Development and design of Case Report Forms (CRFs)- Developed Database Build specifications and coordinated database build and testing activities with database -programmersDefined and test edit checksPerformed data review and query generation/resolutionTracked study progress and issue periodic status reportsProcess/reconcile electronic data received from other data sources, e.g. CIMS, Safety database, labs, IRTOversaw database lock and transfer process.Coordinated and supervise the day-day work of Data Management (DM) staff assigned.Trained and mentored assigned employees on data management procedures and guidelines.Participated/lead internal/sponsor meetings as required, working directly with the assigned project manager and team to provide data management supportEnsured approved study documentation is maintained and properly stored in the trial master files.Managed project resources per budget and within expected timeframes.Assisted with the project training development and delivery, for investigators, clinical sites, project teams, and on data collection processes, tools, and equipment as required.Acted as a point of escalation for data-related issues and queries.

 Oversee sponsor Clinical Data Management project timelines on multiple complex studies or programs. Provide technical oversight of service providers performing core data management functions including CRF/ edit check development, user acceptance testing, data cleaning, listings review, and database lock procedures. Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates risks across programs. Assess the quality of the statistical programming processes through techniques including but not limited to good documentation code review, and testing. Conducts data reviews. Review the development of database specifications, validation plans, and data management plans; ensuring alignment with case report forms, protocol, and safety data standards. Provide input on the clinical data management system enhancements including performing UAT (User Acceptance Testing) Participate in cross-functional process initiatives.