SUSAN MADASU CHRISTUDOSS
AUSTIN,TX
Overview
4
4
years of professional experience
1
1
Certification
Work History
Clinical Data Engineer
Invicro
10.2023 - Current
- Develop custom calculations, error checks, and automated clinical trial data validation routines based off Clinical Trial Protocol and IRC.
- Led end-to-end implementation of multiple high-impact projects from requirements gathering through deployment and post-launch support stages.
- Collaborated on ETL (Extract, Transform, Load) tasks, maintaining data integrity and verifying pipeline stability.
- Designed scalable and maintainable data models to support business intelligence initiatives and reporting needs.
- Advise development of database quality standards including the oversight of standard eCRF library and version control processes
Clinical Data Manager II
PathAI
03.2022 - 09.2023
- Managed all data related activities in clinical trials from designing the study protocol, Data Management Plans, Data Transfer Agreements, eDCs and eCRFs, to conducting data cleaning, querying, and database locking
- Designed clinical data management onboarding plans, wrote SOPs, and Work Instructions adhering to ICH/GCP and CDISC standards
- Co-authored and submitted four clinical research articles currently under review for publishing
- Completed deliverables to external CROs within set timelines and internal budgets, navigating limited resources in a fast-paced start-up environment
- Presented clinical trial results to the FDA, resulting in 510(k) platform approval
- Spearheaded execution and management of clinical studies, ensuring adherence to SOPs and GCP guidelines, with proficiency in electronic Trial Master File (eTMF) management
Clinical Trials Data Coordinator
University of Iowa Cancer Center
05.2021 - 02.2022
- Reviewed proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks
- Managed required records of study activity including case report forms, drug dispensation records, and regulatory forms using Medidata RAVE system
- Conducted remote Electronic Data Capture (EDC) data monitoring and assisted with EDC database lock and data export at the conclusion of studies
- Facilitated quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
- Tracked and reported site protocol deviations, adverse events, and unanticipated adverse device effects to internal stakeholders
Undergraduate Research Assistant
University of Iowa Pediatric Cancer Center
10.2020 - 05.2021
- Worked closely with doctors and researchers to evaluate the neuropsychological effects of existing chemo therapies administered to children in early developmental stages and conducted research to improve the quality of life of patients
- Created databases of childhood cancer survivors and their courses of future treatments, medications, and check-ins using R, SQL, and MS Excel, and MS Access
- Conducted human subject research and recorded data using REDCap
Education
Bachelor of Science - Neuroscience, Computer Science, Pre-Medicine
THE UNIVERSITY OF IOWA
Iowa City, IA05-2021
Skills
- Data Management
- Clinical Research
- Machine Learning
- Data Quality Assurance
- Training and Development
- Project Management
- Jira
- Power BI
- Data Visualization
- Python
- JavaScript
- Pearl
- SAS
- SQL
- AWS
- Git
Certification
- Big Data Analysis, 2017
- Good Clinical Practices (GCP)
- Good Clinical Laboratory Practices (GCLP)
Affiliations
Healthcare Businesswomen's Association (HBA)
Publications
Characterizing academic performance in pediatric acute lymphoblastic leukemia with population-based achievement tests., Journal of Psycho-Oncology
AlKaylani HM, Reasoner EE, Loeffler BT, Mott SL, Madasu SP, Liu A, Langbehn K, Conrad AL, Dickens D, Grafft A, Harshman L, Modi AJ, van der Plas E, Accepted, 09/30/21
Analytical and Clinical Validation of AIM-NASH: A Digital Pathology Tool for Artificial Intelligence-based Measurement of Nonalcoholic Steatohepatitis Histology., National Library of Medicine (NIH)
Hanna Pulaski, Stephen A. Harrison, Shraddha S. Mehta, Arun J Sanyal, Marlena C. Vitali, Laryssa C. Manigat, Hypatia Hou, Susan P. Madasu Christudoss, Sara M. Hoffman, Adam Stanford-Moore, Robert Egger, Jonathan Glickman, Murray Resnick, Neel Patel, Cristin E. Taylor, Robert P. Myers, Chuhan Chung, Scott D. Patterson, Anne-Sophie Sejling, Anne Minnich, Vipul Baxi, G. Mani Subramaniam, Quentin M. Anstee, Rohit Loomba, Vlad Ratziu, Michael C Montalto, Andrew H Beck, Katy Wack, Accepted 05/29/2024
Timeline
Clinical Data Engineer
Invicro
10.2023 - Current
Clinical Data Manager II
PathAI
03.2022 - 09.2023
Clinical Trials Data Coordinator
University of Iowa Cancer Center
05.2021 - 02.2022
Undergraduate Research Assistant
University of Iowa Pediatric Cancer Center
10.2020 - 05.2021
Bachelor of Science - Neuroscience, Computer Science, Pre-Medicine
THE UNIVERSITY OF IOWA
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