KALPEETA ROY
Clinical Data Manager I
New Delhi
Summary
Clinical Data Manager with 3 years of experience in end-to-end data management across global clinical trials. Skilled in SAE reconciliation, query management, and cross-functional coordination. Proficient in EDC systems like iMedidata and Veeva. Recognized for owning POC responsibilities, driving data quality, and delivering risk-managed solutions that enhanced study efficiency and compliance.
Overview
6
6
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Clinical Data Manager I
Caidya
11.2023 - Current
- Served as the primary point of contact and backup for multiple studies, managing full setup from scratch including database testing, task tracking, and timeline planning.
- Independently led SAE reconciliation by identifying and resolving discrepancies, and communicating findings to stakeholders, resulting in improved data quality.
- Performed Quality Control of Edit Checks on Data Validation Plan ‘DVP’ specifications to support the Global Data Standards Initiative and ensure alignment with standardized data review practices.
- Performed SDTM test data entry and sanity testing.
- Performed UAT testing for DM listings.
- Prepared various logs, including data validation issue logs and query management issue logs.
- Generated and updated data management reports, metrics, and issue logs; ensured timely delivery of all key milestones.
- Coordinated closely with cross-functional teams for lab, reconciliations, updating specifications and ensuring data consistency.
- Executed comprehensive query management, data inactivation, LNR entry, and document QC in EDC systems.
- Contributed to study close-out activities including data freezing, final reconciliation, and documentation QC.
- Delivered measurable value by enhancing process efficiency, documentation quality, and risk management across portfolios.
Associate Data Coordinator
clinirx
01.2022 - 11.2023
- Performed Comprehensive Data Review of eCRF's to identify and resolve discrepancies.
- Manage queries and support issue resolution across clinical studies.
- Prepare SOPs and support documentation for data management activities.
- Participate in medical coding using MedDRA and WHO–DDE.
- Perform User Acceptance Testing ‘UAT’ on Rave databases.
- Support data cleaning and develop Data Validation Plans ‘DVP’, Data Management Plans ‘DMP’, and eCRF Completion Guidelines.
Clinical Research Coordinator Intern
THE INCLEN TRUST INTERNATIONAL
12.2021 - 01.2022
- Supported the study coordinator in data clarification, documentation, and source data verification.
Clinical Research Coordinator Intern
Sun Pharmaceutical
11.2021 - 12.2021
- Gained exposure to BA/BE studies and participated in quality control processes under supervision.
Graduate Research Scholar
National Heart Institute
05.2019 - 05.2020
- Trained in OPD and non-invasive cardiac labs ‘ECG, TMT, Echo, Stress Echo).
- Observed cardiac patient assessment, vital signs monitoring, and procedures in Cath Lab and Cardiac OT.
Education
Master of Science - Clinical Research
Jamia Hamdard
11.2020 - 08.2022
Bachelor of Science - Cardiology Lab Technology
Jamia Hamdard
05.2016 - 05.2020
Skills
- Clinical Data Management
- SAE Reconciliation
- Query Management & Data Cleaning
- EDC Systems (iMedidata, Veeva)
- Risk Analysis & Mitigation
- POC & Backup POC Responsibilities
- Lab Reconciliations
- Start-up to Close-out Activities
- Discrepancy Management
- User Acceptance Testing
- Vendor Management
Accomplishments
- Successfully led study setup from scratch as the POC for two projects, coordinating timelines, trackers, and documentation ensuring smooth delivery and proactive risk management.
- Independently managed SAE reconciliation for a key study, identifying and resolving discrepancies and communicating findings, which significantly improved data accuracy and compliance.
Therapeutic Experience
- Oncology
- Psychiatry
- Orthopedic
- Device
- Analgesic
Timeline
Clinical Data Manager I
Caidya
11.2023 - Current
Associate Data Coordinator
clinirx
01.2022 - 11.2023
Clinical Research Coordinator Intern
THE INCLEN TRUST INTERNATIONAL
12.2021 - 01.2022
Clinical Research Coordinator Intern
Sun Pharmaceutical
11.2021 - 12.2021
Master of Science - Clinical Research
Jamia Hamdard
11.2020 - 08.2022
Graduate Research Scholar
National Heart Institute
05.2019 - 05.2020
Bachelor of Science - Cardiology Lab Technology
Jamia Hamdard
05.2016 - 05.2020
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