HEMVANTA PATIL
Clinical Data Management Executive
Navi Mumbai
Summary
Detail-oriented and highly motivated Clinical Data Management Executive with a strong background in oncology research and data operations. Skilled in EDC systems, data integrity, protocol compliance, and GCP guidelines. Proven ability to work across diverse phases of clinical trials, ensuring accurate data collection and regulatory compliance. Seeking to contribute analytical expertise and clinical research insight to a forward-thinking organization.
Overview
4
4
years of professional experience
6
6
Certifications
Work History
Clinical Data Management Executive
ImmunoACT Pvt. Ltd.
02.2024 - Current
- EDC Systems Used: RAVE, REDCap, Veeva Vault, In-house databases
- Demonstrated understanding of Indian oncology landscape and patient-specific requirements for CAR-T therapy
- Supported protocol design and development of CRFs and study-specific documentation
- Participated in all trial phases (I/Ib/II), supporting start-up, conduct, and close-out activities
- Managed multicentric trials across various sites ensuring timely data transfers
- Conducted data cleaning, query resolution, and discrepancy management through EMRs [TATA Memorial, Apollo Hospitals, Amrita Hospitals (Faridabad & Kochi), etc.]
- Performed UAT including test case development, execution, and documentation; created user manuals for CRC training
- Created and implemented SOPs, data validation edit checks, and quality control procedures
- Worked on both paper and electronic CRFs with strong problem-resolution skills
- Contributed to development and validation of proprietary CDM tools and software
Clinical Research Associate
Vasta Bio-Informatics Pvt. Ltd.
10.2022 - 02.2024
- Analyzed oncology data from EMRs and entered into eCRFs using multiple EDC systems (RAVE, Oracle, Jeeva, Tempus, MyTrial)
- Maintained high standards of data integrity, query resolution, and discrepancy tracking
- Ensured protocol adherence and compliance with HIPAA and data protection regulations
- Contributed to 8 oncology trials, including SAE reconciliation and project deliverables
- Participated in client meetings for study progress updates and troubleshooting
- Trained new coordinators and supervised subject visits to ensure data accuracy
- Supported global collaborations with top institutions (MSKCC, FH) and reviewed compliance with ICH-GCP and CDISC standards
Clinical Research Coordinator
Vasta Bio-Informatics Pvt. Ltd.
10.2021 - 10.2022
- Managed clinical trial operations, coordinated with study teams, and maintained compliance with trial protocols
- Prepared trial documentation and ensured timely and accurate data entry
- Attended global study meetings and participated in periodic progress reviews
- Reviewed eTMF documents and worked on Veeva Vault QualityDocs for documentation quality assurance
Education
Diploma - Clinical Research
Clariwell Global Services
Pune, MaharashtraBachelor of Engineering - Biotechnology
Shram Sadhna Bombay Trust's College of Engineering
Skills
- EDC Platforms: RAVE, REDCap, Oracle, Jeeva, Tempus, MyTrial, Veeva Vault
- EMRs & Systems: Memorial Sloan Kettering Cancer Center (MSKCC), FH EMRs, TATA Memorial Hospital & Cancer Research Centre, Apollo Hospitals
- Tools & Software: MS Office Suite, Excel, Veeva Vault QualityDocs
- Standards & Guidelines: ICH-GCP, HIPAA, CDISC, FDA 21 CFR Part 11, IRB, ICMR, CIOMS, CPCSEA, DCGI
- Others: Clinical Trial Operations, ,Clinical Research, Discrepancy Management, Protocol Adherence, Oncology Trials
Certification
Good Clinical Practice (GCP), NIDA Clinical Trials Network, 2021
Accomplishments
- Awarded “Employee of the Quarter” at ImmunoACT.
- Presented and launched ImmunoACT’s proprietary database at CAR-T Summit 2025.
- Participated in the CAR-T Cell Therapy Launch by Hon’ble President of India at IIT Bombay.
- Attended Apollo Cancer Conclave 2024.
- Delivered speech at Voice for BT by Novozymes, D.Y. Patil College.
- Winner – University-level Biotechnology Project Exhibition (2019).
- Gold Medalist – Table Tennis Championship, College Level.
Timeline
Clinical Data Management Executive
ImmunoACT Pvt. Ltd.
02.2024 - Current
Clinical Research Associate
Vasta Bio-Informatics Pvt. Ltd.
10.2022 - 02.2024
Clinical Research Coordinator
Vasta Bio-Informatics Pvt. Ltd.
10.2021 - 10.2022
Bachelor of Engineering - Biotechnology
Shram Sadhna Bombay Trust's College of Engineering
Diploma - Clinical Research
Clariwell Global Services
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