Babitha Gajula

Background

About Babitha Gajula

Served as primary contact for Data Management with all relevant parties including but not limited to Clinical Operations and sponsor stakeholders. • Worked as a Data Team Lead (DTL), as well as a program lead and subject matter expert. • Performed project management responsibilities associated with the documentation, review, cleaning and processing of clinical data collected for investigational drugs. • Designed Case Report Form according to the Clinical Protocol. • Participated in and reviewed many oncology studies at various stages (Phase I, II, and • Created the Data Management Plan, Data Cleaning Plan, and protocol deviation specifications. • Annotated CRFs were created depending on protocol specifications and CDASH standards. • Supported all the studies using Medidata Rave. • Created Quality Control Plan describing appropriate standards for acceptable data quality levels, methods for quantifying data quality and practices to assure data quality. • Created the Data Management metrics on set frequency. • Handled vendor oversight and CRO management, as well as managing in-house projects. • Knowledge of CDISC, CDASH, and CFR 21 PART 11 guidelines. • Analyzed metrics surrounding the activities associated with the acquisition, documentation, review, cleaning and processing of clinical data. • Interpreted study timelines and prioritized workload appropriately to study personnel. • Coordinated the activities of CDM trial team. • Prior to finalizing any outsourcing contracts, we evaluated possible CROs and external vendors for study support skills as well as their ability to adhere to SOPs and quality standards. • Responsible for assisting with research setup, EDC system UAT, and edit/data validation checks. • Participated as data coordination representative in global and local Clinical Data Management initiatives to contribute to the continuous improvement of the processes and technologies utilized within the department. • Lead team with User Acceptance Testing as applicable. • Lead SAE reconciliation and related communication. • Demonstrated ability to analyze data, share trends/observations with team members around results and relevant metrics. • Lead data review and query management. • Performed reconciliation of external data. • Provided ongoing study training and conducted presentations at Investigator meeting site.