Aswani Kumar Bathula
Cary,NC
Summary
Dynamic Clinical Data Management professional with over 7 years of experience supporting Phase I-IV clinical trials across diverse therapeutic areas. Expertise in leading data management activities, overseeing CRO/vendor operations, and ensuring high-quality clinical data delivery in compliance with GCP, ICH, and FDA regulations. Success in collaborating with cross-functional teams, including clinical operations, biostatistics, pharmacovigilance, and external vendors to uphold data integrity and facilitate timely database lock. Proficient in EDC systems, data quality oversight, SAE reconciliation, and database lifecycle management, with a proven track record of delivering robust datasets for regulatory submissions and informed clinical decision-making at Regeneron Pharmaceuticals.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Clinical Data Management Study Lead
Regeneron Pharmaceuticals
New Jersey, USA
03.2024 - Current
- Lead clinical data management activities for global clinical trials ensuring compliance with SOPs, GCP, and regulatory standards.
- Provide hands-on support to internal teams and CRO partners regarding eCRF design, database development, and data quality oversight.
- Oversee data review, reconciliation, and acceptance processes prior to database lock.
- Manage external vendor data transfers, including SAE/AE reconciliation and coding using MedDRA and WHO-DD.
- Monitor data quality metrics and lead issue resolution with CROs and vendors.
- Ensure database lock readiness, including snapshot planning, quality reviews, and study close-out activities.
- Conduct inspection readiness reviews (IRR) and support regulatory inspection preparation.
- Provide IRT-EDC integration expertise and deliver training to internal stakeholders and vendors.
- Identify operational risks and implement mitigation strategies to ensure study timelines are maintained.
- Client: Regeneron Pharmaceuticals
- Employer: Nexpro Technologies Inc
Senior Clinical Data Manager (Consultant)
Regeneron Pharmaceuticals
01.2019 - 03.2024
- Served as primary Data Management lead for assigned clinical trials.
- Coordinated clinical data management activities with CRO partners across study lifecycle.
- Oversaw data cleaning, coding, validation checks, and database snapshots.
- Prepared and maintained key documentation including Data Management Plans, CRF Completion Guidelines, and validation specifications.
- Led CRO oversight and vendor management ensuring adherence to sponsor SOPs.
- Ensured databases were validated and ready for analysis and regulatory submission.
- Managed clean patient tracker reporting and subject data quality monitoring.
- Supported inspection readiness and compliance reviews across multiple studies.
- Collaborated with clinical, biostatistics, safety, and medical writing teams.
- Client: Regeneron Pharmaceuticals
- Employer: Nexpro Technologies Inc
Senior Clinical Data Manager (Consultant)
Regeneron Pharmaceuticals
08.2018 - 01.2019
- Oversaw clinical data management activities including CRO coordination and vendor management.
- Developed Data Management Plans, Data Transfer Agreements, and CRF Completion Guidelines.
- Designed CRFs compliant with CDASH standards.
- Led UAT testing, database validation, and quality control reviews.
- Performed SAE reconciliation and vendor data reconciliation.
- Supported database lock preparation and study close-out activities.
- Client: Regeneron Pharmaceuticals
- Employer: PVR Technologies Inc
Clinical Data Manager
Tekperfekt
01.2018 - 08.2018
- Created and reviewed DMP, DVS, DCS, and annotated CRFs.
- Managed vendor data reconciliation activities including PK, ECG, and laboratory data.
- Implemented post-production database updates and validation activities.
- Conducted quality review of clinical datasets and documentation.
- Served as key client contact ensuring timely project delivery.
Clinical Data Analyst
PVR Technologies Inc
07.2017 - 12.2017
- Performed clinical database setup, validation, and testing.
- Managed data discrepancy management and query resolution processes.
- Conducted SAE reconciliation with pharmacovigilance systems.
- Supported data review and cleaning activities in accordance with study DMP.
- Assisted with clinical data summaries and reporting.
Education
Master’s - Information Assurance
Wilmington University
Delaware, USABachelor’s - Pharmaceutical Sciences
Acharya Nagarjuna University
Andhra Pradesh, IndiaSkills
- Clinical Data Management (Phase I–IV)
- Database Build & Validation
- Data Management Plans (DMP)
- CRO & Vendor Oversight
- SAE / AE Reconciliation
- Data Quality Review & Cleaning
- Database Lock & Archival
- IRT–EDC Integration
- CDISC / CDASH Standards
- Inspection Readiness & IRR Compliance
- Cross-Functional Collaboration
- Risk Identification & Mitigation
- EDC / Clinical Systems
- Medidata Rave (Classic & Rave X), Inform, Oracle Clinical (OC-RDC), Veeva
- Data Review & Visualization
- JReview, Spotfire, RShiny, Looking Glass
- Programming / Data Tools
- SAS (Base & SAS 9 Certified), SQL
- Data Standards
- CDISC, CDASH, MedDRA, WHO-DD
- Productivity Tools
- Microsoft Excel, Word, PowerPoint, Outlook
Certification
- SAS Base Programming Certification (2015)
- AWS Certification (2017)
THERAPEUTIC AREA EXPERIENCE
- Oncology
- Hematology
- Cardiovascular
- Neurology
- Infectious Diseases
- Immunology
- Vaccines
- Rare Diseases
Timeline
Clinical Data Management Study Lead
Regeneron Pharmaceuticals
03.2024 - Current
Senior Clinical Data Manager (Consultant)
Regeneron Pharmaceuticals
01.2019 - 03.2024
Senior Clinical Data Manager (Consultant)
Regeneron Pharmaceuticals
08.2018 - 01.2019
Clinical Data Manager
Tekperfekt
01.2018 - 08.2018
Clinical Data Analyst
PVR Technologies Inc
07.2017 - 12.2017
Bachelor’s - Pharmaceutical Sciences
Acharya Nagarjuna University
Master’s - Information Assurance
Wilmington University