Kalpana Bhethi
King of Prussia
Summary
Clinical Data Management professional with 7 years of experience in clinical research, specializing in data validation, data migration, and lifecycle management across Phase I–III trials. Strong background in EDC systems including Medidata Rave and Oracle Clinical. Experienced in data mapping, cleansing, transformation, and validation, with hands-on involvement in database migration and UAT activities. Solid understanding of workflow-driven systems, regulatory compliance (GxP, ICH-GCP, 21 CFR Part 11), and quality processes aligned with Veeva Vault.
Overview
7
7
years of professional experience
Work History
Medical Services Senior Analyst
Accenture Solutions Pvt. Ltd.
Hyderabad
11.2018 - 03.2020
- Led clinical data management activities for global trials (Neuroscience), ensuring high-quality data delivery
- Supported database migration and upgrade activities, including data validation, reconciliation, and UAT
- Performed data mapping and validation to ensure consistency between legacy and target systems
- Collaborated with cross-functional teams (clinical, programming, vendors) to ensure data integrity and compliance
- Designed and reviewed CRFs, edit checks, and validation rules aligned with protocol requirements
- Executed SAE reconciliation, lab reconciliation, and discrepancy management
- Contributed to workflow-driven processes and lifecycle management aligned with quality systems
- Developed key documents: DMP, DTA, CRF guidelines, and validation documentation
- Supported database lock activities including data review, query resolution, and final validation
- Ensured compliance with GxP, ICH-GCP, and 21 CFR Part 11 standards
Junior Data Analyst
Cognizant Technology Solutions
Hyderabad
05.2017 - 10.2018
- Supported clinical trials (Cardiovascular, Oncology) across full data lifecycle
- Involved in data mapping, transformation, and validation activities
- Performed UAT and system validation testing for EDC systems
- Developed and reviewed study documents (DMP, DRG, CCGs)
- Conducted data cleaning, discrepancy management, and reconciliation activities
- Coordinated with SAS programmers and database teams for edit checks and data validation
- Ensured adherence to regulatory and quality standards
Junior Data Analyst
Cognizant Technology Solutions
05.2014 - 04.2017
- Executed clinical data review, cleaning, and validation for multiple studies
- Supported UAT activities and validation documentation
- Performed data reconciliation and ensured readiness for database lock
- Collaborated with study teams to track progress and maintain data quality
- Assisted in study closeout activities including final data validation
- Client: Novartis
Trainee Junior Data Analyst
Cognizant Technology Solutions
04.2013 - 04.2014
- Developed edit check specifications and executed user acceptance testing (UAT) to ensure data accuracy
- Performed reconciliation of SAE, ECG, and lab data to maintain data integrity
- Generated reports to monitor data quality and study progress for informed decision-making
- Ensured compliance with SOPs and regulatory guidelines
- Client: Sanofi
Education
Master of Pharmacy (M.Pharm) -
University of Mumbai
IndiaBachelor of Pharmacy (B.Pharm) -
University of Mumbai
IndiaSkills
- Data Migration
- Data Mapping
- Data Validation
- Data Cleansing
- User Acceptance Testing
- Workflow Management
- Lifecycle Management
- Clinical Data Management
- Regulatory Compliance
- CAPA
- Deviation
- Quality Processes
- Cross-functional Collaboration
- Study Start-up
- Database Lock
- Medidata Rave
- Oracle Clinical
- Inform
- Veeva Vault
- SAS
- CDISC
- MedDRA
- WHODD
- MS Excel
- MS Word
- MS PowerPoint
- MS Access
- MS Outlook
Additional Information
Strong communication and stakeholder management skills, Experience working with global teams and clients, Quick learner with ability to adapt to new platforms including Veeva Vault applications
Veeva Vault Data Migration Experience - Description
Strong understanding of data migration lifecycle: data mapping, cleansing, transformation, loading, and validation. Experience supporting migration and upgrade activities in clinical systems. Familiar with workflow-based systems and lifecycle-driven processes. Knowledge of Vault objects, workflows, lifecycles, and role-based access (conceptual). Exposure to quality processes (Deviation, CAPA, Change Control). Understanding of tools like Vault Loader (conceptual).
Timeline
Medical Services Senior Analyst
Accenture Solutions Pvt. Ltd.
11.2018 - 03.2020
Junior Data Analyst
Cognizant Technology Solutions
05.2017 - 10.2018
Junior Data Analyst
Cognizant Technology Solutions
05.2014 - 04.2017
Trainee Junior Data Analyst
Cognizant Technology Solutions
04.2013 - 04.2014
Master of Pharmacy (M.Pharm) -
University of Mumbai
Bachelor of Pharmacy (B.Pharm) -
University of Mumbai