Sowmya Mandapati
Hyderabad
Summary
Dynamic R&D Senior Data Steward Manager Associate at Sanofi, adept in data governance and compliance with CDISC standards. Proven track record in enhancing data quality and operational efficiency through cross-functional collaboration. Skilled in metadata management and effective communication, driving impactful solutions in clinical data management.
Overview
11
11
years of professional experience
Work History
R&D Senior Data Steward Manager Associate
Sanofi
Hyderabad
10.2025 - Current
- MDM (Master Data Management): To establish centralized repository of high-quality master data, consistently utilized across the enterprise to drive better insights and operational efficiency.
- Implementation of data governance and data quality frameworks across Regulatory and R&D domains, ensuring alignment with enterprise data policies and compliance standards.
- Collaborated with cross-functional teams (Digital, Regulatory, CMC and R&D) to enforce data standards, streamline governance processes, and maintain data traceability.
- Worked closely with enterprise MDM and RDM systems to standardize and harmonize data structures, improving data reusability and quality.
- Maintained comprehensive documentation on data flows, definitions, hierarchies, and quality standards to support audit readiness and regulatory compliance.
- Handle end to end Data stewardship activities in MDM.
- Work in liaison with Digital/IT and Business in providing clear requirements through JIRA user stories.
- Create functional specification documents for every release of New MDM system.
- Perform Informal testing and draft formal UAT test scripts and execute them in JIRA test board.
- Build data quality rules for each attribute both Offline and Online rules.
- Lead data wrangling workstream to help identify the golden record values while collecting data from multiple systems or teams (GRA/CMC/PV).
- Participating in data governance discussions, data collection analysis and reporting activities.
Lead – Subject Matter Expert
PointCross.com Pvt Ltd
05.2017 - 09.2025
- EDataValidator offers the community an unlimited number of validations for interim and final nonclinical and clinical datasets against the latest SDTM, ADaM, SEND, and Define files. An offline, desktop application is available as part of the standard subscription at no additional cost. Quality control dashboard with interactive views for issue drill down and to determine if a reported issue should be reported in SDRG or if it warrants a corrective action.
- Product Lead for eDataValidator.
- Read and analyze the validation rules released by regulatory authorities and determine the implementation logic for each rule.
- Assess the changes released in new IGs and models released by CDISC and template them to PointCross specific models.
- Propose any new features helpful for validation/regulatory needs of sponsors.
- Conduct Webinar and Demo to industry and clients regarding new product features and releases.
Subject Matter expert
PointCross.com Pvt Ltd
06.2015 - 05.2017
- CTDC (Ipsen) is a “Stage-Gate” process for managing study trail information. Acts as a centralized clinical data repository in standard models. Facilitate designing, analyzing and reporting on clinical trials. Enable fast response to regulatory authority’s enquiry. Establishment of a cross-organizational clinical data warehouse and improves management of Data with external partners (CROs). CTDC enables optimal application maintenance in terms of cost, resources and user friendliness. Translational analytics capabilities to go across the clinical and Non-Clinical data on the same platform. CTDC enables a central storage and exploitation of data from all clinical trials (historical and on-going trials) and allows external integrations (SAS/JReview, TMS coding, Pinnacle... Etc.).
- Provided customer support through weekly meetings, involving problem solving, functional document changes, and corrections.
- Testing the clinical data solutions (software for electronic data submission).
- Validating the product functionalities, data consistency check (preliminary checks which verify define.xml to xpts) and data compliance checks are per FDA validator rules.
- Executed operational qualification for the software functionalities constituting the product quality and release.
- Manage all the product specific documents (Impact analysis, release notes, requirement traceability matrix…etc) to be regulatory compliant (as per CFR Part 11) and for audit purpose.
Member of Technical Staff
PointCross.com Pvt Ltd
07.2014 - 05.2015
- Data Standardization (J & J, Roche, Elusys) Preparation global template to populate the clinical and nonclinical trial data.
- Usage of DS tools (Tagging, OCR) to standardize (Triaging, Extraction, QC check, conversion and upload to SEND template) the received raw data from nonclinical trials to SEND/SDTM format.
- Analyse and reorganize the research data as per CDISC standards (SDTM, SEND) for FDA submissions.
- Standardize the data as per eTOX guidelines for J & J.
- Validate the standardize data as per FDA nonclinical validator rules.
- Mapping the controlled terminologies - GLOBAL TAXONOMY MAPPING on every quarterly release of CDISC CTs (SDTM, ADaM & SEND).
- Quality analysis of Clinical and Translational data solutions and validate the data through data review tools like ToxVision and IGO (interactive graphical objects).
Education
Advance diploma - Clinical Research and Clinical data management
ICBIO
BangaloreMSc - Biotechnology
DNR College PG Courses
BhimavaramBSc - Biotechnology, Biochemistry, chemistry
Aditya Degree college
KakinadaSkills
- Clinical Data Management
- Data governance
- Basic SAS
- Data Standards Compliance (CDISC)
- FDA, PMDA, CDISC Validation Rules
- Definexml
- Study master data management
- MS Office
- Informatica MDM
- Data standardization
- Cross-functional collaboration
- Documentation management
- Stakeholder engagement
- Effective communication
- Problem solving
- Training and mentoring
- Metadata management
- Data quality management
Timeline
R&D Senior Data Steward Manager Associate
Sanofi
10.2025 - Current
Lead – Subject Matter Expert
PointCross.com Pvt Ltd
05.2017 - 09.2025
Subject Matter expert
PointCross.com Pvt Ltd
06.2015 - 05.2017
Member of Technical Staff
PointCross.com Pvt Ltd
07.2014 - 05.2015
Advance diploma - Clinical Research and Clinical data management
ICBIO
MSc - Biotechnology
DNR College PG Courses
BSc - Biotechnology, Biochemistry, chemistry
Aditya Degree college
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