Headline

Senior eTMF Specialist | Veeva Vault Expert | Certified in AI & Health Informatics (IPA) | Clinical Document Strategist

About

With over 5 years of experience in the Clinical Research industry, I have built a strong foundation in clinical trial documentation, regulatory compliance, and quality assurance — with a specialized focus on electronic Trial Master File (eTMF) management. In my current role as a Senior eTMF Specialist, I oversee end-to-end quality checks of eTMF and Patient Safety documents, ensuring audit-readiness, regulatory alignment, and documentation integrity across all phases of clinical trials. I bring deep hands-on expertise in Veeva Clinical Vault, managing document workflows with precision and efficiency. What sets me apart is my commitment to extreme accountability, ownership, and excellence — I don’t just complete tasks, I take full responsibility for outcomes and consistently raise the bar for quality and compliance. I am also a certified professional in AI in Clinical Research and Health Informatics — a credential that reflects my passion for innovation and my drive to integrate emerging technologies into clinical operations for smarter, faster, and more compliant trial execution. 🌟 What I bring to the table: ∙ End-to-end eTMF Quality Assurance & Compliance ∙ Patient Safety Document Management ∙ Veeva Clinical Vault Expertise ∙ AI-driven insights in Clinical Research ∙ Strong stakeholder engagement & cross-functional collaboration ∙ Initiative-driven mindset with a passion for continuous improvement I am deeply passionate about advancing clinical research through technology, quality, and human dedication — because at the heart of every trial is a patient whose life depends on our precision. 📩 Open to connecting with professionals across Clinical Research, Regulatory Affairs, and Health Technology.

Location

Mumbai Metropolitan Region

Work experience

Specialist at Tata Consultancy Services, Sep 2021 - Present · 4 yrs 11 mos, Scope of this project is to handle Veeva Clinical Vault (VCV). Processing of Documents received on Share Point from Document Submitter and Performing Quality Check of Clinical eTMF Documents according to Checkpoints and Uploading it in VCV. Scope of this project is to perform Periodic Quality Check in VCV of Studies to ensure completeness of documents filled in TMF safety reporting zone under Patient Safety owned Artifacts. Instructed teams to work within relevant service requirements, statutory limitations and legal frameworks. Steered customer engagements Supported business leaders in productivity and performance goal-setting. Devised targeted marketing strategies by inculcating process improvements which resulted in boosting quality of Trial related documents to 99% from 96% KPI.

Senior Process Associate at Tata Consultancy Services, Sep 2020 - Present · 5 yrs 11 mos, Mumbai, Maharashtra, India

Information Specialist at Tata Consultancy Services, Sep 2020 - Jul 2021 · 11 mos, Managed Patient Information by preparing and adhering to the pre-launch guidelines and Fulfilled accurate coding using MedDRA Terminologies to weed out every possible issue causing hurdles for seamless Case Processing. Undertook the responsibility of maintaining Lessons Learned sheet and modified Repository of previously made errors accordingly to ensure accuracy. Played a crucial role in scrutinizing and evaluating customer ratings and feedbacks and provided essential insights to the top management to improve brand identity and customer. Technical Preparation of Documents including pre - assessment of case. Extraction of all Medical information for patient into applicable extraction form including review of all source documents assigned to respective reporter. Adopted effective demand forecasting strategies and maintained inventory accordingly which resulted in a 15% decrease in errors and a 10% improvement in overall quality.

Intern at Oxford International School, Nov 2017 - Feb 2018 · 4 mos, Mumbai, Maharashtra, India, 4 months of Internship as Science Teacher

Education

Master's degree, Biotechnology, Chikitsak Samuhas Sir Sitaram and Lady Shantabai Patkar College of Arts and Science and V R Varde College

Bachelor of Education - BEd, Biology/Biological Sciences, General, Bal Bhagwan Shikshan Prasarak Mandals Oxford B.Ed.College Sector-V Charkop Kandivali(W) Mumbai 400 067