Sign In
 [New User? Sign Up]
Mobile Version

Advanced Business Analyst - EDC System

Bengaluru, KA
Job Code:
  • Biotechnology & Science
Applying for this job will take you to an external site
  • Shortlist
  • Email Friend
  • Print

Job Details

The key objectives for the position are related to the areas described belowManaging changes and new releases end to end on EDC system & standard reports with GXP compliance. This includes collecting requirements from the business (LoB), performing IQ/OQ/PQ, reporting to ensure successful deployment of the change /release. Participate in new releases, defect management, test coordination / validation, quality risk assessment, Design review etcValidation responsible for EDC system & Standard Reports which includes compliance management, handling of remarks & Non Conformities, for both EDC & Standard Reports..Managing periodic reviews(URR etc) which includes supporting the system with pulling reports required for reconciliation of users accesses.Validation & set up of interface from EDC system for each new clinical trials including customization of interfaces in certain cases. (EDC-IMPACT)Interface Co-ordination of all systems in R&D SolutionsSecurity patches testing for EDC & IVRS systemInvolved in validation tasks for EDC system/patch upgrades.To ensure validated state of the IT System and to work closely with NNQA to fulfil the overall quality assurance responsibility.Support system manager on the system management activities as and when requiredMust be able to collaborate and communicate with stake holders, vendors & external parties.Excellence in business and system understandingDemonstrate pro-activeness and ownershipManage own time planning and timely deliverablesCommunicate and involve relevant stakeholdersEnhancing good team spirit and high degree of knowledge sharingCompliance with QBIQParticipate in system operation and maintenance in IT System Management.Incident Support
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BE/ B.Tech (Engineering)

Experience: 8-13


Business/Systems Analysis
Applying for this job will take you to an external site


© Copyright 2015 Al Nisr Publishing LLC - powered by Gulf News