Job Description:
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 group
3. 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 documented
17.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 place
20. Where appropriate, ensures a mentor is assigned (including managers)
21. Ensures adequate resources are in place
22. Reports to Director if there are any additional unanticipated demand for resources Novartis is an Equal Opportunity Employer.

Minimum requirements
University or college degree in life science, computer science, pharmacy, nursing or equivalent relevant degree.

Experience/Professional requirement:
1. Ideally 10 or more years’ experience in clinical data standards with at least 8 years in Clinical Data Management
2. At least 5 years’ line management or global project team leadership experience
3. Strong technical and problem solving skills, and ability to evaluate computer systems to support clinical data collection standards/data management
4. Excellent understanding of clinical data collection standards CDISC, SDTM
5. Understanding of GCP

Additional Information:
Industry Type: Pharma/ Healthcare/ Clinical research
Location: India
Functional Area: R&D
Job ID: 199616BR
Last Date: 25th November, 2016

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