Job Title:  TRAINING CONSULTANT

Job Summary

Introduction

About NIIT

NIIT provides comprehensive and scalable managed training services for learning administration that maps directly to our customer needs. Training is our business and passion. We are one of the largest training outsourcing provider in the world. NIIT delivers and administers 75,000 days of training each year, in 18 languages. We have designed and developed over 50,000 days of classroom training and 20,000 hours of web based training localized to more than 25 languages. NIIT is a global service provider. We have presence in more than 40 countries.

Link for our LinkedIn page: https://www.linkedin.com/company/niitmts/mycompany/
Link for our website : https://www.niit.com/en/learning-outsourcing/

Professional Experience & Competence:

8 - 10 Years of Sr CRA experience            
2-3 years of Line Management or Project Management             
Excellent Communication (English & Local Language if applicable)              
Soft skills awareness
Clarity on ICH-GCP Guidelines, specifically Essential Documents.  
Practical Exposure to maintenance of Investigator and central file.
Perform source data verification, and reconciliation of adverse events for market research programs.
Familiarity and/or experience with electronic Trial Master File systems (eTMF).
Familiarity and/or experience in defect tracking and reporting using Clinical Data Review System & manual tracking
Ability to convey SOP requirements theoretically and practically
Industry certifications pertaining to technical areas and/or training will be highly appreciated.
Someone with regulatory background would be an added advantage.

NIIT is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Educational Qualification

• A Bachelors graduate in Pharmaceutical Science with familiarity working on clinical trial master file documentation, data management, clinical operations and pharmacovigilance.
• Excellent communication and organization skills coupled with through knowledge of ICH-GCP and essential documents involved in clinical trials and regulatory.
• Familiarity with systems like Oracle Clinical, OC-RDC, RAVE, Inform
• Knowledge of different software to file documents electronically like right track, GDMS, ELARA, ELVIS etc. would be preferred.

Experience

• 4–6 years of relevant experience in training, learning consulting, or learning delivery operations.