Divya K

Dynamic and detail-oriented professional with a robust background in Clinical Data Management and extensive experience in the biotechnology industry. Strong foundation in Clinical Research principles and procedures enables excellence in data management roles. Committed to advancing clinical research by leveraging academic expertise and a passion for innovation within a reputable organization. Eager to drive impactful contributions that enhance data integrity and support groundbreaking discoveries.

• Advanced Post Graduate Diploma in Clinical Research and Clinical Data Management- Cliniminds Academy Pursuing
• Proficient in ICH-GCP guidelines, emphasizing ethical conduct and scientific integrity in clinical trials. Understanding of regulatory compliance across trial phases with focus on participant right, safety and well-being. Familiar with stakeholder responsibilities including sponsor, investigators, ethics committees and monitors. Knowledge of Essential Documents, Protocols, Informed Consent forms, and Case Report Forms.
• Familiar with Data Management Plan, Exposure to screen UAT testing and Edit Check UAT testing for system validation, Understanding Data Integration and harmonization strategies, knowledge of medical coding workflows and discrepancy management and query resolution, familiar with External Data Reconciliation, SAE Reconciliation, Awareness of Quality Management System in Clinical Research.
• Certification course on Good Clinical Practice -NIDA Clinical Trial Network March.2025
• The certification showcases proficiency in safeguarding participant rights, ensuring safety, and upholding data integrity. This 12-module course is a must for research staff engaged in clinical trials, with the certificate remaining valid for 3 years within NIDA CTN. It guarantees adherence to international standards for ethical and scientific quality in clinical research.
• Certification course on Clinical Research and Data Management -BCRI Bangalore February.2025
• Basics of Clinical research, gained knowledge on Clinical trial phases, Regulatory compliance, ICH-GCP guidelines, IRB/IEC, Protocol designs, Informed consent process, maintaining Standard Operating Procedures, Data collection, CRF designs, Data entry, Electronic Data Capture, EDC systems, Data Management Plans, basics of discrepancy management, medical coding and MedDRA and WHO-DD dictionaries, AE /SAE collecting and reporting, Data lock and Archiving
• Clinical Research Beginner’s Course on Udemy February.2024
• Gained knowledge in preclinical and clinical trial Phases, ICH-GCP guidelines, Regulatory compliance, Informed Consent Process etc.