CHIRAG VAZIRANI
Mumbai
Summary
Clinical Data Management professional with 6+ years’ experience in external data review, vendor data reconciliation, and database lock activities across global Phase I–III clinical trials. Proven expertise in EDC tools (Medidata Rave, Oracle Clinical, Veeva), edit check design and validation, and CDISC-compliant data standards. Skilled in mentoring, process optimization, and cross-functional coordination. Currently seeking a Senior Clinical Data Specialist role to leverage leadership potential and advanced technical skills.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Data Specialist
Fortrea (Formerly Labcorp)
Bangalore
05.2024 - Current
- Led review and query resolution for multiple global studies, ensuring 100% on-time deliverables per sponsor timelines.
- Executed special listings and reconciliation discrepancy programs to maintain data accuracy and compliance.
- Participated in study start-up activities including local lab mapping, UAT testing, and edit check validation.
- Generated and QC’d data listings for internal review and sponsor meetings.
- Reviewed Edit Check Specifications (ECS) and Database Specifications (DBS) for accuracy.
- Created and tested dummy data for SAS reports, edit checks, and database screens.
- Contributed to process improvements, reducing database lock timelines by 15%.
- Mentored new hires on project-specific processes and external data review SOPs.
External Data Reviewer
Fortrea (Formerly Labcorp)
Bangalore
04.2023 - 04.2024
- Managed electronic vendor data for labs, PK, imaging, ensuring protocol compliance and accurate database mapping.
- Developed Data Transfer Agreements (DTA) and Data Transfer Specifications (DTS) for vendor data transfers.
- Reviewed data discrepancies from edit checks and managed full query resolution lifecycle.
- Performed validation reviews of transmitted data before database loading.
- Conducted QC for local laboratory normal ranges and coordinated with clinical teams to resolve discrepancies.
- Assisted with automation of SAS lab edit checks and validated checks in DEV, UAT, and PROD environments.
- Trained junior team members and provided SME input on external data processes.
Associate External Data Reviewer
Fortrea (Formerly Labcorp)
Bangalore
08.2021 - 03.2023
- Conducted external data reviews ensuring all protocol-specified parameters were captured and formatted correctly.
- Supported validation reviews and performed QC checks for local lab normal ranges.
- Collaborated with vendors to resolve discrepancies and ensure data quality prior to database lock.
Clinical Data Analyst
Accenture Solutions Pvt Ltd
Bangalore
10.2018 - 07.2021
- Specialized in Rave and Oracle Clinical; performed third-party reconciliations for labs, PK, and tumor tissue datasets.
- Reviewed, analyzed, and validated clinical trial data for accuracy per project-specific guidelines.
- Created and processed Data Clarification Forms (DCF) and managed discrepancy resolution.
- Supported multiple database locks delivering error-free datasets to statisticians.
- Received ACE Award and multiple recognition awards for quality delivery and proactive issue resolution.
Education
Bachelor of Pharmacy -
Prin. K.M. Kundnani College of Pharmacy
MumbaiSkills
- Clinical Data Management
- External Data Review
- Vendor Data Reconciliation
- Query Management
- Edit Check Design
- Specification Review
- Testing
- SAS Report Testing
- Validation
- Database Lock
- Unlock Activities
- ETMF Documentation
- Study Status Reporting
- CDISC Standards
- GCP Compliance
- SOP Compliance
- EDC Tools
- Medidata Rave
- Oracle Clinical
- Veeva
- Cross-Functional Collaboration
- Mentoring
Certification
- Certified Associate in Project Management (CAPM), In progress, 2025
Languages
- English, Full Professional Proficiency
- Hindi, Full Professional Proficiency
- Marathi, Professional Working Proficiency
Awards Recognition
- WOW Award – Client recognition for database lock excellence
- ACE Award – For handling critical study and resolving issues efficiently
- Smiley & Encore Awards – Accenture Management appreciation
Timeline
Clinical Data Specialist
Fortrea (Formerly Labcorp)
05.2024 - Current
External Data Reviewer
Fortrea (Formerly Labcorp)
04.2023 - 04.2024
Associate External Data Reviewer
Fortrea (Formerly Labcorp)
08.2021 - 03.2023
Clinical Data Analyst
Accenture Solutions Pvt Ltd
10.2018 - 07.2021
Bachelor of Pharmacy -
Prin. K.M. Kundnani College of Pharmacy
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