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Associate Director, Clinical Data Standards

Secunderabad, Telangana
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  • Biotechnology & Science
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Job Details

Job Purpose (State in one sentence the overall objective of the job)Responsible and accountable for managing, directing and coordinating Clinical Data Collection Standards activities within Oncology Data Sciences Operations. Contributes to thestrategy of Oncology Data Sciences Major Activities (Describe 8-12 main activities)1. Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports including managers and ensures high quality performance management across Data Operations Group. 2. Establish a partner and customer-orientated Oncology Data Sciences Operations group3. Leads and oversees all aspects of clinical data standards with a predominant focus on strategic and technical leadership, driving state-of-the-art/cutting edge data management and standards development; responsible for the end-to-end data standards, metadata, governance and functional/technical excellence to enable efficient clinical data/ information across the full spectrum of development supporting decision making and regulatory submissions while ensuring state of the art interoperability of systems supporting development processes. 4. Drives the vision for clinical data standards to effectively support Novartis' clinical research strategy, from collection through submission.5. Collaborates closely with Oncology Global Development, to ensure that Oncology standards packages are defined, measured, managed and used to improve efficiency and quality of clinical trial collection, analysis, reporting and submission. 6. Represents the Oncology Business Unit on Data Standards Governance (DSG) committee to ensure core standards needs of the unit are met.7. Leads Oncology data governance process to ensure consistent data standardization is enforced across Development; overall accountability for the functioning of the Data Standards. 8. Functionally manages staff supporting the development of new Novartis data standards.9. Initiates and leads business process changes in the context of data standardization as well as required capabilities to support standards education (new terminology, approach, and context) and training (data standards implementation, CDISC - ODM, SDTM, ADAM). 10. Works with external organizations to develop best practices and advance clinical data standards.11. Participates as a recognized Novartis leader to selected external data standards working groups within HL7, CDISC, and ICH. 12. Provides input to and undertake the implementation and maintenance of global working practices and standards.13. Contributes to the development of the Clinical Data Management organization through his/her global leadership role on the management team. 14. Represents Clinical Data Collection Standards at cross-functional forums, meetings and provide timely feedback to partners.15. Leads and supports clinical & non-clinical special projects. 16. Supports the establishment of training programs (technical and professional skills) for Clinical Data Management staff and ensure staff training is conducted and properly documented17. If required, deputizes for the responsibilities of the Operational/Functional Manager 18. Participates in Health Authority inspections as required Version 1.0_18Dec2015 Page 2 19. Ensures that each associate has an up to date training and development plan in place20. Where appropriate, ensures a mentor is assigned (including managers) 21. Ensures adequate resources are in place22. Reports to Director if there are any additional unanticipated demand for resources Novartis is an Equal Opportunity Employer.
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 10-15


Chemical Research | Data Management/ Statistics | Documentation/ Medical Writing | Quality Assurance/ Control
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