Senior Clinical Data Manager in Global Development team
Category: Clinical Development and MedicalLocation:
Bangalore, Karnataka, IN
Are you looking for the opportunity to make our patients’ lives better and leave your footprint! Then maybe you are the “Senior Clinical Data Manager” we need for an exciting project.
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 has witnessed significant transformations right from providing DM services to IO region reporting to IOCDC to becoming an integral part of Global development from Aug 2010. 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.
As Senior Clinical Data Manager your key responsibility is to strategize execution of clinical trial and clinical trial business processes which includes execution of clinical projects and handle Quality Control (QC) documents.
Simultaneously, the role will also include to involve yourself in the process of outsourcing and collaboration with vendors/Clinical Research Organization (CRO). In addition, you will be responsible for managing projects related to clinical trials and follow data management standards of validation and derivation procedures.
Additionally, you will be involved in large complex trials and strategize the team with knowledge about drug development process.
Key success criteria will be to become an expertise in data programming languages and tools which includes to understand the interface and integration between OC – TMS – EDC system – IVRS. You hold and strive to have a good collaboration with stakeholders and take responsibility to perform tasks independently and in accordance with Novo Nordisk SOPs, Novo Nordisk policies and the Novo Nordisk Way.
Hence, a strong understanding of data management and clinical trial, being able to generate new ideas, providing thorough analysis, formulate and present recommendations will be expected to drive GCP expectations.
As a person you are ambitious, proactive and ability to interact with people at all levels in the organisation. You hold a M. Sc / B. Sc degree in Life Science or comparable degree in medicine, nursing, pharmacy, veterinary science or clinical information management or equivalent qualifications.
You are expected to have deep strategic knowledge of clinical development, medical coding and CRF design, preferably 4-5 years of data management experience and the majority of this within Pharma Industry.
Working at Novo Nordisk
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes, obesity and other therapy areas. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.
For further information, please contact Sunidhi at email@example.com
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