Prajakta Sable

eTMF QC specialist/Veeva vault/CRC/TCS

Role: Etmf Specialist at Tata Consultancy Services
Location: Pune, IN
LinkedIn followers: 500 followers

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About Prajakta Sable

Hello, I am Prajakta Sable. I am Post-graduated in pharmacy with demonstrated…

Experience

Etmf Specialist
Tata Consultancy Services
Mar 2024 — Present · Pune, IN
eTMF QC Specialist- Overseas and ensure the accuracy of clinical trial document,following strict guidelines and regulatory standards like ICH-GCP and 21 CFR Part 11.Responsible for conducting quality checks, making necessary corrections, and ensurecompliance. Update and maintain client need.Clinical Record Contract- Dealing with the naming, identification, categorization andarchiving of documents produced during clinical trial of drugs by using the eTMF tool.Handled various tools like Veeva Vault, eTMF Tool and microsoft office.Strengthen interpersonal skills and experience mentoring junior eTMF QC reviewers,contributing to team success.Work collaboratively with the technical team and re-route the documents to the dataprocessing team work flow.Track and review TMF master index and support document review as needed to ensureaccurate and timely documentation of clinical trial data.

Education

Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm
2017 — 2021
Padmashri Dr. D.Y.Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune 411018
Master's degree

Contact information

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Current company

Tata Consultancy Services

IT Services and IT Consulting · 726K employees · Founded 1968 · Mumbai, India

Tata Consultancy Services (TCS) is the technology partner of choice for industry leading organizations worldwide. Since its inception in 1968, TCS has upheld the highest standards of innovation, engineering excellence, and customer service. It has set an aspiration to become the world's largest AI-led technology services company and is enabling its clients to transform themselves across the full AI stack, from infrastructure to intelligence. Rooted in the heritage of the Tata Group, TCS is focused on creating long term value for its clients, its investors, its employees, and the community at large. With a highly skilled workforce spread across 55 countries and 202 service delivery centers across the world, the company has been recognized as a top employer in six continents. With the ability to rapidly apply and scale new technologies, the company has built long term partnerships with its clients – helping them emerge as perpetually adaptive enterprises. Many of these relationships have endured into decades and navigated every technology cycle, from mainframes in the 1970s to artificial intelligence today. TCS sponsors 14 of the world’s most prestigious marathons and endurance events, including the TCS New York City Marathon, TCS London Marathon and TCS Sydney Marathon with a focus on promoting health, sustainability, and community empowerment. Caution against fraudulent job offers: TCS doesn’t charge any fee throughout the recruitment process. Refer here: https://www.tcs.com/careers/india/recruitment-fraud-alert

tcs.com

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About Prajakta Sable

Experience

Etmf Specialist

Education

Savitribai Phule Pune University

Padmashri Dr. D.Y.Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune 411018

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