Sandra Barfield Email and Phone Number

• Primary oversight representative for eCS/Sponsor data management interaction, to ensure adherence to eCS data management process, deliverable quality standards, and timelines within approved scope for their Oncology, Dermatology and Gastroenterology programs.• Functioned as senior DM consultant to sponsor providing guidance on the application of data management best practices to sponsor’s protocol and study.• Delegated and prioritized team tasks, providing support and guidance to study data management team mentoring junior level staff and peers on all associated tasks with a study, helping to grow team member capabilities.• Maintained project documentation related to assigned tasks.

• Working concurrently on multiple data management projects, with little to no guidance from functional manager/PDM.• Reconciling project reports, listings and other documents generated in data management against a database for accuracy and completeness of data management processes.• Perform all tasks to relevant Chiltern and/or Sponsor SOPs, ICH or other regulatory guidelines in DM.

• Worked collaboratively with several departments to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting. Utilized reports to track study progress and ensured timeliness and quality expectations were met.• Ensured completeness, correctness and consistency of clinical data and data structure.• Reviewed study protocols and assisted in the planning and implementation of the data management portions of clinical research projects.

• Functioned as Lead in designing, developing, validating, and maintaining databases for clinical trials using provided clinical database management software or other validated applications. Created and/or maintained project and company programming packages and libraries.• Provided complete and accurate documentation of clinical databases consistent SOPs, protocols and data management plans. Led efforts in writing departmental documentation.• Defined, implemented and tested data quality checks in PL/SQL according to the management plan.• Participated in internal and external team meetings and other clinical programming and data management activities, as required. Performed all other related duties as assigned.