Dancing, Gardening, Traveling, Cooking
Akshatha Kantharaju
Clinical Data Programmer | Veeva EDC & Inform Expert | Clinical Database Development | CDISC (CDASH, SDTM) | EDC Programming & Validation
Bangalore
Summary
Detail-oriented Clinical Data Programmer with extensive expertise in Veeva EDC and Oracle Inform, specializing in study build, rules programming, edit checks, and mid-study updates. Proficient in eCRF design and data validation, with a strong understanding of CDISC standards (CDASH, SDTM) to ensure the delivery of high-quality, compliant, and submission-ready datasets. Demonstrated ability to manage multiple studies simultaneously while effectively resolving discrepancies and supporting cross-functional teams to achieve efficient clinical trial solutions. Committed to leveraging technical skills and industry knowledge to enhance data integrity and drive successful project outcomes.
Overview
6
6
years of professional experience
3
3
Certifications
Work History
Senior EDC Programmer
Sitero
04.2024 - Current
- Interacting and collaborating with other study team members (Sponsor and Sitero) to support the build and maintenance of EDC studies, to ensure quality data collection, user experience, and regulatory compliance.
- Designing and developing eCRFs/Study Database based on sponsor and internal Clinical Data Management (CDM) provided documents, such as the study protocol and other additional documentation, as applicable.
- Reviewing and incorporating Testing/UAT feedback on Study Design and eCRFs from EDC SPQC, Internal CDM, and Sponsors' team members.
- Maintaining a strong understanding of EDC, supporting software, and internal standards.
- Maintain and contribute to the Sitero library of standard EDC, CDASH-compliant CRFs.
- Designing and developing edit checks.
- Interacting and collaborating with other study team members (Sponsor and Sitero) to support the build and maintenance of edit checks to ensure quality data collection, user experience, and regulatory compliance.
- Writing, validating, and implementing applicable edit checks based on the specifications provided by the Sponsor and Internal Clinical Data Management teams.
- Reviewing and incorporating testing/UAT feedback on edit checks from EDC SPQC, internal CDM, and sponsors team members.
- Supporting project management with post-production changes (impact analysis) that are not directly related to protocol amendments or study configurations, for example: duplicate resolutions, subject data transfers, etc.
- Designing and developing the eConsent database based on sponsor-provided documents, such as the ICF and other additional documentation, as applicable.
- Maintaining a strong understanding of eConsent, supporting software, and internal standards.
- Audit and verify clinical database entries to identify and resolve data inconsistencies.
Senior Clinical Database Programming Associate
Accenture
03.2020 - 04.2024
- Hands-on experience with Veeva CDMS for EDC programming and study builds.
- Proficient in eCRF development, rules programming, and study deployment activities.
- Strong expertise in Veeva study configuration, including eCRFs, events, schedules, and EDC tools.
- Solid understanding of Veeva CDMS object hierarchy, and post-production change processes.
- Experience in interacting with clients to address EDC programming-related questions and issues.
- Ability to organize, prioritize, and manage multiple deliverables in fast-paced environments. Enthusiastic about learning and adapting to new domains and technologies.
- Skilled in designing and developing clinical study databases, including eCRF generation, edit check validation, IVRS design, EDT, and LNMT.
- Proficient in integrated programming and application enhancements to support end-to-end clinical trial success.
- Strong focus on ensuring data accuracy, integrity, and compliance with regulatory standards.
- Developed and validated edit checks with multiple actions, including dynamic rules, casebook variables, comparison rules, and email notification rules.
- Managed end-to-end study startup from initiation through release, including lab analytes setup, and external vendor data handling.
- Created study data extracts, prepared detailed specifications, and ensured accurate documentation for study builds.
- Supported integrations with IRT, medical coding systems, local labs, and external vendors to enable smooth data flow and compliance.
- Use Inform to screen and enroll subjects, track visits, raise and resolve queries, and evaluate clinical study data. InForm is an electronic data capture (EDC) application that manages, stores, and retrieves data generated from clinical trials.
- Having knowledge of clinical therapeutic areas.
- Create a study-specific eCRF image.
- Knowledge of External Data Transfer and Interactive Voice Response System.
- Participates in UAT, Go Live.
- Demonstrated strong organizational and time-management skills while managing multiple projects.
- Set up an SQL database on cloud servers to store client data for query analysis.
- Demonstrates a working knowledge of protocol.
- Develops a working knowledge of database standards and the study development process.
Education
B.E - Computer Science and Engineering
Don Bosco Institute of Technology
Bengaluru, India01.2019
Pre-University College -
KLE Independent PU College
Bengaluru, India 04.2001 -
S.S.L.C -
SAVM Public School
Bengaluru, India01.2013
Skills
- Tools: Inform, Veeva CDMS, Oracle Health Science Support, Central Designer, DMW, Mentor EDC, eConsent, Kiosk Questionnaire, SQL Server Management Studio (SSMS)
- Programming & Query Languages: SQL, C#, Python, VBScript, XML, Postfix
- Version Control: Git
- Data Science & Analytics: Machine Learning (Supervised & Unsupervised Learning), Statistics, Hypothesis Testing, Exploratory Data Analysis (EDA)
- Operating Systems: Windows, VMware
- Project Management Skills: Agile methodology, Requirement gathering, Documentation, Cross-functional team collaboration, Study build lifecycle management
Certification
‣ Obtained EMC Academic Associate Certification on Data Science and Big Data Analytics from EMC2.
Interests
Accomplishments
- Awarded as BEST MENTEE for my sincere dedication towards learning in training phase at Accenture.
- Have Received Encore Awards 2021 CORE VALUE CHAMPION AWARD for fostering and bringing company’s core values to life at Accenture.
- Have Received Encore Awards 2022, 2023 STAR OF BUSINESS AWARD for creating client value through business outcomes at Accenture.
- Obtained reward recognition from the client for having zero production issues.
- Obtained reward recognition for winning Spectra Quiz organized by Accenture.
- Supervised team of 14 staff members and provided regular Knowledge sessions on the required Skills.
- Won SKIPPING CHAMPION from Bangalore at INDIA LEVEL Competition held at Accenture.
DECLARATION
I hereby declare that all the information given above is correct as per my knowledge. Date: Place: Bangalore
Timeline
Senior EDC Programmer
Sitero
04.2024 - Current
Senior Clinical Database Programming Associate
Accenture
03.2020 - 04.2024
Pre-University College -
KLE Independent PU College
04.2001 -
B.E - Computer Science and Engineering
Don Bosco Institute of Technology
S.S.L.C -
SAVM Public School
Similar Profiles
Dilip ReddyDilip Reddy
Project Manager, Mentor RTSM at SITEROProject Manager, Mentor RTSM at SITERO
Ritama BharRitama Bhar
Drug Safety Associate at Sitero solutions Pvt. Ltd.Drug Safety Associate at Sitero solutions Pvt. Ltd.
Manasa C Manasa C null
Senior Automation Engineer I at Sitero Solutions India Private LimitedSenior Automation Engineer I at Sitero Solutions India Private Limited
Sourav GhoshSourav Ghosh
Research Analyst-IT at Globsyn I.T Services (p) LtdResearch Analyst-IT at Globsyn I.T Services (p) Ltd
Simran SSimran S
Travel Consultant at BCD TravelTravel Consultant at BCD Travel