Profile for B1 Jobs in Kolkata

Profile for B1

WIPRO

1 to 2 Years

Not disclosed

Expired

Posted: 14 May 20

Profile for B1

Kolkata

Operations

Experience : 1-2 Years

Job Code : 52125

Job Description:

Job Title: Team Leader B1 level (Full time employment)
Skillset: e-TMF/ Document Specialist
Line of business: Medical Devices & Pharma Services
Work timings: 24/ 7 rotational (night shifts will prevail)
Work Location: Kolkata (candidate who is out of transport boundary will have to relocate to Kolkata vicinity as per our transport team guidelines)
Department: Wipro DOP  Hierarchy in Wipro: Associate (AA) then Team Leader (B1) then Group Leader (B2) then Senior Group Leader (B3) then Manager (C1) then Senior Manager (C2)

Responsibilities:

Understanding of clinical documents Trial Master File (TMF)- like, Safety, Submission and R&D related documents
Ensure the understanding of Clinical Trials in general
Ensure the identified properties and features from clinical documents are correct
Have understanding of artifacts and attributes associated with documents
Conduct Quality Checks involved Working Experience in:
Clinical document management system
Clinical research monitoring, pharmaceutical, CRO or healthcare industry
Knowledge of ICH GCP, 21 CFR part 11 regulations
Working knowledge of clinical essential documents, including trial master file and clinical submission documents
Basic Minimum Qualification Requirement: Bachelors/ Masters Degree in Life Sciences, Pharma, Clinical Research and/or a Scientific Degree