Novo Nordisk Clinical Documentation Associate in Global
Development Bachelor’s degree preferably in Life Science or comparable degree
in Computer Science, Information Technology, Clinical Information Management
Category: Clinical Development and Medical
Location: Bangalore, Karnataka, IN
We are looking for a Clinical Documentation
Associate in the Global Development (GD) unit based out of Global Service
Centre (GSC), Bangalore, India. You can look forward to an exciting job driving
different projects and engaging with multiple stakeholders at the global level
About the
department
The data
management department was established in Bangalore, India in the month of
September 2007 and has significantly grown from 10 members to a strong team of
over 119 Clinical Data Management professionals. It is a young, enthusiastic
and dynamic team with varied skillsets and professionals from diverse
backgrounds such as Pharmacy, Life-Sciences, Physiotherapy, Computer/Information
Sciences and Business Administration. The key objective of the department is to
ensure high quality data delivery to the stakeholders. The involvement of
various groups in data management is significant in key stages of trial setup,
conduct and closeout.
The position
The main job
task in this role is to perform data entry of Clinical trial data from paper
case report forms to the clinical data base as per project timelines with
acceptable level of quality. In this position you will ensure efficient
handling of Case Report Forms (CRFs) as per Novo Nordisk Standard Operation
Procedures (SOPs) and departmental requirements from receipt until archival.
You will also perform Scanning, Scaling and preparing trial level CRFs by
segregating into Clinical Trail Report (CTR) and non-CTR subjects and support
Electronic Case Report Forms (eCRFs) preparation for submission deliverables at
the project level to make them Electronic Common Technical Document (eCTD)
compliant and on Clinical Data Interchange Standards Consortium (CDISC)
document preparations.
The tasks of
the Clinical Documentation Associate will, to a large extent, be performed
independently and in accordance with Novo Nordisk SOPs, Novo Nordisk policies
and the Novo Nordisk Way. The Clinical Documentation Associate is recognised as
responsible for supporting end users and must act independently, following the
strategic objectives of the standards governance bodies and the company in
general and has no budgetary duties.
Qualifications
You are
expected to have the below skills and knowledge.
Bachelor’s
degree preferably in Life Science or comparable degree in Computer Science,
Information Technology, Clinical Information Management or equivalent
qualification
0-1 year data entry experience; preferably on
clinical database systems
Computer
literacy and proficient in Microsoft Office tools
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