Clinical Database Programmer
On-site · Bengaluru, Karnataka, India
Job Summary
Clinical Database Programmers are responsible for providing technical support and oversight for the Medidata Clinical Cloud (MCC) implementation. They design, develop, and test clinical databases (including forms, folders, matrices, data dictionaries, edit checks, derivations, and reports), perform peer reviews of others' work, and ensure compliant database builds and EDC standards (Global Library, Edit Checks, CRF modules). They manage timely, quality deliverables for study teams, serve as an EDC SME advising Data Management and operations on Medidata Rave functionality, and apply knowledge of MCC modules (Coder, RTSM, Lab Admin, iMedidata/Cloud Admin) along with related tools. Proficiency with MCC, Rave EDC, and related clinical trial systems (ePRO, CTMS, IVRS/IWRS) as well as reporting tools (Business Objects, JReview, Cognos, Crystal Reports) is preferred, and strong communication and organizational skills are essential.
Required Qualifications
- Bachelor’s degree or equivalent work experience preferred
- 2+ years in Pharmaceutical/Biotechnology industry or equivalent preferred
- Experience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages
- Professional Skills: communication, teamwork, multitasking, detail orientation
- Technical Skills: Proficiency in MS Office (MS Project, MS Excel), ICH/GCP, 21 CFR Part 11, Medidata MCC Rave EDC, multicompartment modules (Coder, RTSM, Lab Admin, iMedidata/Cloud Admin)
- Experience with data reporting tools: Business Objects, JReview, Cognos, Crystal Reports
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