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Clinical Database Developer

3 months ago

Bengaluru, Karnataka, India capstone Full time

Job Description :
Minimum 7 years in Pharmaceutical/Biotechnology/Medical Device industry or equivalent

  • Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages
  • Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities (SDLC) and CDISC standards (CDASH, SDTM) Excellent verbal and written communication skills
  • Detail oriented, ability to multitask with strong prioritization, planning and organization skills
  • Excellent team player
  • Minimum 5 years' experience with Medidata Rave platform, including Architect. Certified RAVE Developer highly preferred.
  • Custom Functions programming experience using C# An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
  • Experience with Database programming is a plus: Oracle, SQL Server
  • Familiarity with other EDC Systems: Oracle InForm, IBM Merge preferred
  • Experience with

Business Intelligence Tools:
Business Objects, JReview, Cognos, or related
)