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Expert Clinical Data Manager

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

Responsible for the Data Management (DM) start-up activities across assigned trials, indications or programs including electronic Case Report Form (eCRF) design and generation of the data handling and data review plans2. Ensures consistency on the design of trials within a program/indication 3. Maintains standards within a program/indication4. Identifies trends in the data and possible solutions for efficiencies 5. With support from Program Clinical Data Manager (PCDM) ensures study conventions, processes, knowledge sharing and best practice exist for all assigned trials6. Skilled on a range of systems/tools in use by Novartis and by Contract Research Organization (CRO) partners and how to work with each accordingly 7. Effectively refines requirements for data validation based on metrics generated and les-sons learned from cleaning activities8. Responsible for ongoing review of data, database maintenance & creation / maintenance of study documentation 9. Ensures the review of listings for quality, content, format and output10. Supports & assists junior staff for assigned trials (e.g. raising data issues for Data Review Team (DRT) attention) 11. Responsible for the final review of data and finalization of the study documentation12. Responsible for the final review of listings for quality, content, format and output 13. Tracks and reports status and progress for assigned trials, indications or programs. Is proactive to ensure timely deliverables (incl. Snapshots and interim/final locks).14. Ensures appropriate tracking systems are kept up to date 15. Ensures creation of study specific project plans16. Prepares feedback information about sites query performance and data entry compliance 17. Plans appropriately to ensure adherence to timelines, including assignment of workloads and identifying resource and timeline issues within and across programs18. Interacts at International Clinical Teams (ICTs) and Biometrics and Data Management (BDM) Project Teams 19. Ensures adherence to GCP, DM standards, SOPs/Working Practices (WPs) and process guidelines20. Able to effectively represent DM in SOP reviews and updates 21. Participates in Health Authority Inspections and assists in responding to requests for information from Health Authorities on DM related topics.22. Responsible for managing all study documents required during a Regulatory or internal auditNovartis is an Equal Opportunity Employer.
Additional Degree: B.Pharm. (Pharmacy)

Experience: 6-10


Bio-Technology Research | Chemical Research | Documentation/ Medical Writing
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