Kowdi Manisha
Bengaluru,India
Summary
Clinical Data Specialist with 3+ years of experience in Clinical Data Management supporting global clinical trials. Experienced in Medidata Rave X, Medidata Classic and Veeva Vault EDC with expertise in clinical data review, query management, UAT, edit checks, data cleaning and database quality. Strong knowledge of ICH-GCP and cross-functional collaboration.
Overview
3
3
years of professional experience
5
5
years of post-secondary education
Work history
Clinical Data Specialist
IQVIA
Bengaluru
03.2026 - 07.2026
- Reviewed clinical trial data according to DMPs and protocols, ensuring adherence to regulatory standards.
- Generated, reviewed, and resolved data queries to maintain data integrity and support timely study progression.
- Conducted UAT for study databases to ensure accuracy and functionality.
- Performed edit checks to identify discrepancies in data entries. to identify missing or inconsistent data.
- Collaborated with study teams for timely data cleaning.
- Ensure compliance with ICH-GCP and SOPs.
Clinical Data Analyst
Fortrea
Bengaluru, India
10.2025 - 02.2026
- Generated and resolved clinical data queries, ensuring completeness and accuracy of high-quality clinical databases.
- Reviewed clinical trial data in accordance with Data Management Plans (DMPs), Edit Check Specifications, and Data Review Guidelines.
- Performed manual and automated data review activities to identify missing, inconsistent, or erroneous clinical data.
- Ensured compliance with ICH-GCP guidelines, sponsor requirements, and internal SOPs while maintaining audit-ready databases.
- Conducted User Acceptance Testing (UAT) for study databases and verified system functionality before production release.
- Supported Database Freeze, Interim Analysis, and Database Lock activities within project timelines.
- Reviewed SAS edit checks and listings, coordinating work requests to facilitate timely issue resolution.
- Performed vendor reconciliation activities and maintained external data trackers to ensure data consistency.
- Generated sponsor reports including Clean Patient Tracker (CPT), Open Query Backlog, Pending SDV reports, and weekly Data Management metrics.
- Collaborated with CRAs, CTLs, sponsors, and cross-functional teams, enhancing efficiency in resolving clinical data issues.
Associate Clinical Data Analyst
Fortrea
Bengaluru, India
09.2024 - 10.2025
Assistant Clinical Data Analyst
Fortrea
Bengaluru, India
08.2023 - 09.2024
Clinical Data Management Intern
Fortrea
Bengaluru, India
02.2023 - 08.2023
Education
M.Sc. - Biotechnology
VIT
India 01.2021 - 01.2023
B.Sc. - Biotechnology, Genetics & Chemistry
Loyola Academy
Hyderabad 01.2018 - 01.2021
Skills
- Clinical Data Management
- Clinical Data Review
- Data Validation
- Data Cleaning
- Query Resolution
- Edit Checks
- UAT
- EDC Systems
- Database Lock Support
- ICH-GCP
- Audit Readiness
- Microsoft Excel
ACHIEVEMENTS
Recognition Awards for Database Lock and Interim Analysis support., Published review article on bioactive nanoparticles.
SYSTEMS
- Medidata Rave X
- Medidata Classic
- Veeva Vault EDC
- Microsoft Excel
- Word
- PowerPoint
THERAPEUTIC EXPERIENCE
- Oncology
- Cardiology
Timeline
Clinical Data Specialist
IQVIA
03.2026 - 07.2026
Clinical Data Analyst
Fortrea
10.2025 - 02.2026
Associate Clinical Data Analyst
Fortrea
09.2024 - 10.2025
Assistant Clinical Data Analyst
Fortrea
08.2023 - 09.2024
Clinical Data Management Intern
Fortrea
02.2023 - 08.2023
M.Sc. - Biotechnology
VIT
01.2021 - 01.2023
B.Sc. - Biotechnology, Genetics & Chemistry
Loyola Academy
01.2018 - 01.2021