Clinical Database Programmer

3 months ago

Bengaluru, IndiaMid Level

Responsibilities

Design, develop, and test clinical databases, including forms, folders, matrices, dictionaries, edit checks, derivations, custom functions, and reports.
Perform peer reviews of clinical studies built by other Clinical Database Programmers.
Develop, maintain, and ensure compliance of database builds and EDC standards for clinical studies.
Manage timely, high-quality study deliverables for assigned protocols and studies.
Serve as an EDC subject matter expert, providing Medidata Rave guidance and best-practice recommendations to data management, operations teams, and stakeholders.
Maintain working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata, and Cloud Admin.

Bachelor’s degree or equivalent work experience preferred.
Two or more years of pharmaceutical or biotechnology industry experience or equivalent preferred.
Experience gathering requirements and developing CRF, edit-check, and site-query specifications.
Understanding of database structures and programming languages, including C#.
Expert knowledge of Medidata Clinical Cloud, particularly Medidata Rave EDC capabilities and best practices.
Familiarity with ePRO, IVRS/IWRS, CTMS, and clinical trial methodology.
Preferred knowledge of ICH/GCP guidelines and 21 CFR Part 11.
Preferred experience with Business Objects, JReview, Cognos, Crystal Reports, or related reporting tools.
Strong communication, collaboration, prioritization, planning, organization, and independent problem-solving skills.

501-1,000 employees