Novo Nordisk Clinical Data
Manager Pharmacy/ M. Sc / B. Sc Life Science or medicine, nursing, , veterinary science
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.
The Position:
As Clinical
Data Manager your key responsibility is to coordinate and support the main Data
Management roles for the trial in ensuring DM documentations, Data handling
including timely completion of discrepancy management activities for assigned
projects following appropriate regulatory guidelines, company and department SOPs
Simultaneously,
the role will also include Ensuring the integrity of clinical trial databases,
perform data validation for ensuring completeness and make data availability to
relevant stakeholders by generating reports in a timely manner and also ensure good
documentation practices are followed.
Handle
interim analysis as directed by the trail data manager depending on the trial
characteristic. Also as Clinical Data Manager you need to be in alignment with
Trial Stakeholders to identify risks and incorporate preventive/mitigating
plan. And also you should secure that all trial work is adhered to current DM
standards. This includes in the trial set up phase: Laboratory set up (incl.
lab parameters), paper CRF and eCRF modules, global validation/derivation procedures
in CDMS/EDC and standard annotations.
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. Also you will be 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
Qualifications
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.
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