Summary
Overview
Work History
Education
Skills
Certification
Interests
Timeline
Intern
Rachel Sneha G

Rachel Sneha G

Senior Clinical Documentation Associate
Bengaluru,India

Summary


Experienced Project Clinical Data Manager with understanding of end to end Clinical Data management process.

Experience working with international regulations for product and regulatory submissions such as BLA, MAA, IND, NDA

Comprehensive understanding on regulatory guidance documents 21 CFR part 11, GMP, GCP and ICH guidelines

Overview

11
11
years of professional experience
4
4
years of post-secondary education
3
3
Certifications

Work History

Senior Clinical Documentation Associate

Novo Nordisk Service Centre India Pvt
Bengaluru, IN
09.2018 - Current
  • Gained strong leadership skills by managing projects globally
  • Ensure documents at the project level are eCTD compliant
  • Managing vendors and ensuring eCOA /EDC sponsor packages are handled
  • Reviewing SDTM validation files to ensure the documents are submission ready
  • Acted as a team leader in group projects EMA and PMDA submissions, delegating tasks and providing feedback.

Clinical Documentation Associate

Novo Nordisk Service Centre India Pvt
Bengaluru, IN
04.2014 - 09.2017
  • Adaptable and proficient in learning new concepts quickly and efficiently.
  • Developed strong communication and organizational skills through working on group projects.
  • Handling of eCRF as per regulatory requirements until archival

Process Executive

WPA-World Class Service
Bengaluru, IN
04.2012 - 01.2013


• To obtain and maintain high quality
of 96% in all work modules.
• To contribute positively towards the
team.
• To take accurate, logical and consistent
decisions defined procedures
and rules, while processing all work
modules.

Education

Clinical Data Management

PG Diploma From Lotus Clinical Research Academy
Bangalore, India
01.2011 - 12.2011

Bachelor of Science - Microbiology

Mount Carmel College
Bangalore, India
01.2007 - 06.2010

Skills

Project Management

undefined

Certification

Python Basics

Interests

Dancing

Bike riding

Timeline

Python Basics

12-2022

Project management and leadership

06-2022

Informal Communication

07-2021

Senior Clinical Documentation Associate

Novo Nordisk Service Centre India Pvt
09.2018 - Current

Clinical Documentation Associate

Novo Nordisk Service Centre India Pvt
04.2014 - 09.2017

Process Executive

WPA-World Class Service
04.2012 - 01.2013

Clinical Data Management

PG Diploma From Lotus Clinical Research Academy
01.2011 - 12.2011

Bachelor of Science - Microbiology

Mount Carmel College
01.2007 - 06.2010
Rachel Sneha GSenior Clinical Documentation Associate