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4 weeks ago
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
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