AISHWARYA BABU
Austin,TX
Summary
With 9 years of experience in data management activities, I have a comprehensive understanding of the entire process, including action planning, database locking, and standard operating procedures. My expertise lies in supporting the consistent implementation of globally agreed study delivery and clinical development strategies, particularly in DM operations. As an enthusiastic and project-oriented team player, I excel in communication and interpersonal skills, enabling effective collaboration and the development of innovative solutions.
Overview
9
9
years of professional experience
Work History
Associate Data Team Lead
IQVIA Biotech
02.2021 - Current
- Operational experience in Data Management (DM) that has spanned the full duration of studies, from study start-up to database lock on various global/multi-national studies (Phase I, II, III) across USA, South America, Europe, Africa, Asia, and India with significant experience working on Cardiovascular, Oncology, Vaccines, Head and Neck Cancer, Non-Small Cell Lung Cancer, Follicular Carcinoma studies.
- The responsibilities include independently manage end-to-end delivery of data management services for single/multi-service projects, ensuring quality deliverables on time and within budget, providing comprehensive data management expertise to the Clinical Data Management (CDM) team, leadership and vision to the team in the areas of project planning, execution, and close-out; financial management; communications; and milestone deliverables to ensure high quality data management products that meet the customer needs.
- Reduced data discrepancies through the implementation of robust validation checks and error resolution procedures.
- Coordinated efforts with biostatistics teams for insightful analysis reports that informed key decision-making processes.
- Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively.
Clinical Data Manager
AstraZeneca
02.2018 - 10.2020
- Developed and Maintained project documents like Data validation documents, Data Management plan (DMP), CRF completion guidelines (CCGs), Data Transfer Agreements (DTA) and Departmental SOPs
- Perform Quality Check of the data by manual review
- Reviewed and tested eCRF screen design and written data management plans for EDC and paper-based trials
- Handled Complete life cycle of Data Management in Phase 2 and 3(From study setup to close out)
- Managed team of three on oncology study
- Conducted team meetings; managed weekly schedules and confirmed accuracy of timesheets
- Performed Lab reconciliations and SAE Reconciliations
- Involved in creating Edit check specification and performing UAT
- Freeze and lock the data on time for preparing the database for statistical review, interim quality review and final database lock
- Implemented solutions to issues that arise during the development, management and close out of clinical studies
- Handling and maintenance of Trial Master File (TMF)
- Developed annotated CRF's based on the protocol specifics and CDASH requirements
- Resolved data discrepancy and related issues by interacting directly with investigator sites
- Work closely with database developers, Biostatisticians, both internal and external team.
Clinical Data Coordinator
ICON
09.2015 - 01.2018
- Performed data management tasks: data review, discrepancy management, listing review, quality control and reported status reports to client
- Generated and reviewed EDC/UAT functionality, comprehensiveness and edit checks
- Assisted in developing case report forms and CRF completion guidelines
- Assisted the Clinical Data manager with manual data reviews and worked with database lock activities
- Performed a weekly task which includes SAS listings review, IVRS and LAB reconciliation, SAE reconciliation, handling and documentation
- Ensure all adverse events are collected pursuant to GCP and follow up on reported serious adverse experiences.
Education
Bachelor of Medicine and Surgery (M.B.B.S) -
Tianjin Medical University
Skills
- Data Review
- E CRF Specifications
- Edit Check Specifications
- UAT
- Query Management
- Vendor Reconciliation, SAE Reconciliation
- Medidata Rave, Oracle, InForm
- SAS Programming
- Outlook, MS Word, MS Excel, and MS PowerPoint
- Bachelor of Medicine, Bachelor Of Science
- Strong and comprehensive CDM skills in study start-up, study conduct and close out activities
- Developing CRF design, Edit Check Specifications, Reconciliation Specifications, Vendor set up, Listings Specification, Missing Page Report Specification, etc
- Proficient in performing User acceptance testing (UAT) including validating data entry screens, edit check specifications in EDC tools and reporting to database programmer for errors
- Discrepancy management, trend analysis and resolution of subject data in compliance with SOP's
- Executed study close out activities and final data base lock
- Working experience in developing Data Transfer Agreements (DTA) with external vendors
- Ensured the studies are conducted as per the SOPs, ICH GCP, protocol requirements and standard guidelines
- Ability to work efficiently with global teams to ensure deliverables
Timeline
Associate Data Team Lead
IQVIA Biotech
02.2021 - Current
Clinical Data Manager
AstraZeneca
02.2018 - 10.2020
Clinical Data Coordinator
ICON
09.2015 - 01.2018
Bachelor of Medicine and Surgery (M.B.B.S) -
Tianjin Medical University
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