Clinical Database Programmer

Responsibilities

• Design, develop, and test clinical databases including forms, folders, matrices, data dictionaries, and edit checks
• Perform peer reviews for studies built by other Clinical Database Programmers
• Maintain and ensure compliance of database builds and EDC standards, including Global Library and CRF modules
• Manage timely and high-quality deliverables for assigned protocol/study teams
• Act as an EDC Subject Matter Expert (SME) providing guidance on Medidata Rave functionality to Data Management and operations teams

Requirements

• Bachelor's degree or equivalent work experience
• 2+ years of experience in the Pharmaceutical or Biotechnology industry
• Experience with requirements gathering and design of CRFs, edit checks, and site queries
• Proficiency in C# programming language
• Expert knowledge of Medidata Clinical Cloud (MCC) and Rave EDC capabilities
• Proficiency in Microsoft Office, specifically MS Project and MS Excel
• Familiarity with clinical systems such as ePRO, IVRS/IWRS, and CTMS
• Excellent English verbal and written communication skills

Preferred Qualifications

• Knowledge of additional Medidata Rave modules (Coder, RTSM, Lab Admin, iMedidata/Cloud Admin)
• Strong knowledge of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodology
• Experience with data reporting tools like Business Objects, JReview, Cognos, or Crystal Reports