AISWARYA PANICKER
@aiswaryapanicker
Clinical data management SME delivering compliant, high-quality Phase I–III trial data.
IndiaWhat I'm looking for
I’m a Clinical Data Management SME with nearly 7 years of experience managing global Phase I–III clinical trials, including Oncology therapeutic area studies, end-to-end across study conduct, reconciliation, and database lock activities.
I drive discrepancy management and data review with strong expertise in Medidata Rave, Oracle InForm, and Veeva, using logic checks and manual/SAS-based validations to ensure data accuracy, consistency, and integrity. I also lead vendor reconciliation for SAE, PK, IWRS, and Central Lab data, and execute UAT and edit check review to confirm system and protocol compliance.
I’m known for improving data quality metrics, supporting audit readiness, and ensuring timely study delivery while maintaining ICH-GCP and sponsor SOP compliance. I collaborate across stakeholders, mentor teams, and build study metrics dashboards and clean patient trackers to improve query turnaround times and DBL readiness.
Experience
Work history, roles, and key accomplishments
Spearheaded conduct and close-out clinical data management across the study lifecycle, ensuring ICH-GCP, sponsor SOP, and regulatory compliance. Led data review, discrepancy management, and end-to-end vendor reconciliation (including SAE/PK/Central Lab/IWRS), achieving 100% reconciliation compliance prior to database lock and reducing open issues before DBL.
Managed discrepancy management and EDC data review activities across multiple clinical studies using Medidata Rave and InForm. Coordinated issue resolution with sponsors, CRAs, and external data providers, including PK/laboratory/IWRS and SAE reconciliation, and supported database lock readiness with DBL trackers and status reporting.
Handled discrepancy resolution for clinical study datasets using Medidata Rave and supported data reconciliation aligned to protocol requirements. Produced ad-hoc/custom listings and reports, reviewed edit checks and laboratory listings, and coordinated with overseas clients to close issues on time.
Contributed to study setup, conduct, and database lock-related clinical data management activities. Executed discrepancy management and data reconciliation (including UAT and SAE reconciliation), and created metrics and trend dashboards to support site-level issue identification and study tracking.
Clinical Data Analyst
Inventurus Knowledge Solutions
Jul 2018 - Sep 2019 (1 year 2 months)
Analyzed electronic health records by reviewing patient medical histories and clinical documentation to evaluate health status. Used Citrix-based systems for data collection, validation, and documentation, and communicated relevant insights to primary care physicians.
Food Technology Intern
Bhabha Atomic Research Centre
Jan 2017 - May 2017 (4 months)
Conducted research on citric acid esterification and rice digestibility, developing shelf-stable ready-to-eat lemon and tamarind rice using radiation technology. Evaluated irradiated psyllium gum for application in Indian food products and supported experimental work with analytical problem-solving.
Education
Degrees, certifications, and relevant coursework
D.Y. Patil University, Navi Mumbai
Bachelor of Technology, Biotechnology
Grade: 70.83%
Earned a B.Tech in Biotechnology from the School of Biotechnology and Bioinformatics. Graduated with 70.83%.
B.S.G.D Junior College, Maharashtra
Higher Secondary Certificate (HSC), Higher Secondary
Grade: 60.33%
Activities and societies: Represented the girls’ football team as an active team member.
Completed the Higher Secondary Certificate (HSC) at B.S.G.D Junior College. Graduated with 60.33%.
St. Sebastian’s English School, Maharashtra
Secondary School Certificate (SSC), Secondary Education
Grade: 81.27%
Completed the Secondary School Certificate (SSC) at St. Sebastian’s English School. Graduated with 81.27%.
Availability
Location
IndiaAuthorized to work in
Job categories
Skills
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