Mohit Kumar
Bengaluru
Summary
Accomplished Data Operations Coordinator, proficient in clinical trial coordination, data quality assurance, and regulatory compliance, with a strong focus on patient safety and protocol adherence. Skilled in statistical analysis, problem-solving, and cross-functional collaboration, driving excellence in medical research initiatives.
Overview
1
1
year of professional experience
1
1
Certification
Work History
Data Operations Coordinator (DOC)- CTRI/2024/01/06
SurgiDerma Hospital
Bangalore
08.2023 - Current
- Company Overview: Data Operations Coordinator for a randomized, triple-blind, placebo-controlled trial assessing the analgesic effect of preoperative Gabapentin on peri- and postoperative pain in minor surgeries
- Supported database development and data review processes, including data collection, verification, and entry to ensure compliance with Good Clinical Practice (GCP) and regulatory standards
- Coordinated data entry and documentation for data clarifications, addressing and resolving data discrepancies to maintain data accuracy
- Monitored adverse events and contributed to patient safety assessments, assisting with documentation of treatment-emergent adverse events (TEAEs) to uphold ethical standards
- Collaborated with Data Operations Coordinators (DOCs) and interdisciplinary teams (physicians, data managers, clinical analysts) to support project progress, protocol adherence, and effective team communication
- Data Operations Coordinator for a randomized, triple-blind, placebo-controlled trial assessing the analgesic effect of preoperative Gabapentin on peri- and postoperative pain in minor surgeries
Education
Doctor of Pharmacy -
Gautham College of Pharmacy
Bengaluru12-2024
Skills
- Clinical Trial Coordination
- Data Accuracy & Quality Control
- Data Compliance & Confidentiality
- Database Testing & Validation
- Medical Coding (ICD-10, MedDRA)
- Adverse Event Reporting
- Statistical Analysis: (T-tests, Exploratory Data Analysis, Data Transformation)
- Data Analysis & Interpretation
- Data Clarification & Resolution
- Leadership in Data Management
- Attention to Detail & Problem-Solving
Certification
- ICH-GCP
- MS Excel Tips and Tricks
- Data Analytics
- Advanced course in Pharmacovigilance
- SQL Hackerrank assessment (intermediate level)
- SAS
GAIN Study (Gabapentin Project)
Conducted a randomized, triple-blind trial on Gabapentin's analgesic effect for perioperative pain, providing data-driven insights to enhance pain management in minor surgeries. Ensured data accuracy, GCP compliance, adverse event monitoring, and pain assessment using VAS and NRS scales.
Descriptive Study on New-Onset of Epilepsy(Academic project)
Analyzed patient demographics, symptoms, and treatment outcomes in new-onset epilepsy across age groups, generating data to guide clinical and public health strategies. Demonstrated expertise in data collection, CRF development, and maintaining research reliability.
Timeline
Data Operations Coordinator (DOC)- CTRI/2024/01/06
SurgiDerma Hospital
08.2023 - Current
Doctor of Pharmacy -
Gautham College of Pharmacy
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