Clinical Documentation Associate in Global Development at Novo Nordisk

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Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post : Clinical Documentation Associate in Global Development

Job Description
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.

Candidate Profile
• 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

Additional Information
Qualification : B.Pharm or a graduation in Life Sciences

Experience : 0-1 years
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Clinical Development and Medical

End Date : 30th April, 2020

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