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Brinda CA
Clinical Data Management
Bengaluru
Summary
Clinical data management professional with 3 years of experience in comprehensive data management activities throughout the start -up, conduct and close-out for clinical trials, Have a strong foundation in data acquisition, operations, validation, reconciliation, and documentation. Expertise is characterised by a focus on data quality, compliance, and timely delivery. Proficient in executing CDM activities such as protocol and CRF review, UAT execution, cleaning, query management, data reconciliation, and database lock support. Skilled in industry-standard systems like Oracle Inform, Veeva Vault, and DMW, and have practical experience with SQL, Python, and Spider tools to enhance data analysis and efficiency.Recognized for my precision, commitment to quality, and effective collaboration with clinical data acquisition and operations, I am a quick learner who adapts to new technologies and methodologies. Dedicated to using my clinical data management expertise to improve the success and integrity of clinical research.
Overview
5
5
Languages
3
3
years of professional experience
Work History
Clinical Data Management Associate
Accenture
Bengaluru, India
09.2023 - Current
- Oversaw end-to-end delivery of clinical data within start-up, Conduct & Close-out activities in Oncology, Vaccine, and Neuroscience therapeutics.
- Conduct activities such as SAE /Vendor data reconciliation (Labs PK, PD, Central lab ,Biomarker, Imaging, ECG etc) ,query management, post go live changes, manual data listing review and data cleaning activities etc.
- Experience in Set up activities such as protocol, electronics case report forms ( eCRF) review, data management plan and review. Test script review for edit checks, creating DTS and UAT.
- Oversaw end-to-end delivery of clinical data during start-up and close-out activities in oncology, vaccine, and neuroscience therapeutics, ensuring alignment with project timelines and quality standards.
- Created high-quality documents for all external vendor data types, including safety lab, ePRO, imaging, biomarker, ECG, and PK.
- Collaborated with cross-functional teams to streamline data collection and reporting procedures.
- Developed and maintained data management processes to ensure data accuracy and consistency.
- Collaborated with onshore and client teams to develop Data Transfer Specifications (DTS) and Controlled Terminology (CT) in accordance with eCRF, protocol, and sponsor requirements, enhancing data consistency and integrity.
- Supported UAT activities using test files to ensure correct import of external data into clinical database (CDB) as per client standards.
- Served as SME for External Document Review (EDR) to ensure alignment of documents with study requirements and performed upload, review, and approval in Veeva Vault eTMF.
- Served as biomarker SME, leading monthly vendor governance meetings.
- Expertise in Oracle Inform (4.2, 6.3, 7.0),Veeva Vault,DMW, DIU,SQL, Spyder, Anaconda Python,Rave,MS Office. Hands-on experience in Integrated, PDAM-NG & PDAM-NG 2.0.
Education
Bachelor of Science - Biotechnology, Chemistry and Gentics
Jyoti Nivas College
Bengaluru, India 04.2001 -
HIGHER SECONDARY - PCMB
Jyoti Nivas Pre-University
Bengaluru, India06-2019
Skills
Startup, Conduct & Close-out activities
Standard mock data creation and SQL validation
Familiar with DMP, DTS, DRP, Annotated CRF, Protocol & ICH-GCP
Knowledge in eCRF review & database design
Expertise in data validation, data collection, reconciliation (SAE & vendor) Query management and Data cleaning activities
Data listing review, DB locking, freezing & essential document archival
Proficient in Veeva Vault, Oracle, Inform, Rave SQL, Spyder & Anaconda Python
Strong multitasking, organization, time management
Accomplishments
Honored with the Star of Business Award twice: Q1 FY24 and H2 FY25, for outstanding efforts in generating client value through successful business outcomes.
CORE COMPETENCIES
- Clinical Data Management: Data acquisition, User Acceptance Testing, SAE/Vendor data reconciliation, Query management, Data cleaning, Listing review, Database lock & archival.
- Tools: Oracle Inform, Veeva Vault, Rave, DMW, SQL, Spyder, Anaconda Python, MS Office.
- Documentation & Standards: Create CT & DTS, DMP, Annotated CRF, Protocol review, CDISC/SDTM compliance.
Interests
Timeline
Clinical Data Management Associate
Accenture
09.2023 - Current
Bachelor of Science - Biotechnology, Chemistry and Gentics
Jyoti Nivas College
04.2001 -
HIGHER SECONDARY - PCMB
Jyoti Nivas Pre-University