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Job Title : Senior Clinical Data Manager

Location : Bangalore

About the department:

GD-GSC-Data Management Unit supports Projects and Trial Management on operational Data Management activities of clinical projects. 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 major activities handled include CRF Design, Database Programming, Data Entry, Data Validation, Medical Coding, Lab data handling, Data analysis & migration, Database Lock, Hyperlinking and Bookmarking and Project Management. These opportunities have in turn fostered a deeper understanding with an ability to drive, contribute to process and share best practices while leveraging cross-cultural collaboration towards a unified mission to achieve clean data GD-GSC-Data Management Unit supports Projects and Trial Management on operational Data Management activities of clinical projects. 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 major activities handled include CRF Design, Database Programming, Data Entry, Data Validation, Medical Coding, Lab data handling, Data analysis & migration, Database Lock, Hyperlinking and Bookmarking and Project Management. These opportunities have in turn fostered a deeper understanding with an ability to drive, contribute to process and share best practices while leveraging cross-cultural collaboration towards a unified mission to achieve clean data.

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The Position:

  • Ensuring the integrity of clinical trial databases.
  • Perform Data Validation ensuring completeness and clean data.
  • Ensure availability of data to relevant stakeholders.
  • Write, send, update, and resolve data clarifications.
  • Create test cases and test validation procedures.
  • Perform UAT of the database.
  • Generate reports and communicate with stake holders in a timely manner
  • Understand and comply with all applicable standard operating procedures and working instructions.
  • Develop and maintain good communications and working relationships with Data Management team.
  • Assist in timely scanning, book marking and indexing of documents in novoDOCS
  • Ensure good documentation practices are followed.
  • The Clinical Data Manager in alignment with Trial Stakeholders should be able to identify risks and incorporate preventive/mitigating actions in the plan.
  • The Clinical Data Manager should have attention on irregularities, deviations and should therefore be capable of foresee, identify and diagnose problems and is able of making relevant proposals for actions.
  • The tasks of the Clinical Data Manager will, to a large extent, be performed independently and in accordance with Novo Nordisk SOPs, Novo Nordisk policies and the Novo Nordisk Way.

Qualifications:

  • M.Sc / B.Sc in Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications.
  • Preferably 5-6 years of data management experience and the majority of this within Pharmaceutical Industry or Development.
  • Preferably knowledge of Clinical Development and project Management
  • Preferably experience in stakeholder management and presentation skills
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Note : Freshers and candidate without Clinical Data Management experience need not apply.

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