KEY TASKS RESPONSIBILITIES

- Design/develop and test clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, standard and custom reports
- Performs peer review for the studies built by other Clinical Database Programmers
- Responsible for the development, maintenance, and compliance of database builds and EDC standards in support of clinical studies including, but not limited to, Global Library, Edit Checks, CRF modules
- Manages timely-quality deliverables for the study teams for assigned protocol/study(s)
- Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams, and other stakeholders on basic Medidata Rave functionality
- Working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules.
- Other duties as assigned

CANDIDATE S PROFILE

Education Experience

- 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

- Ability to work creatively and independently to carry out assignments of a complex nature
- Ability to communicate and work effectively and cooperatively with other skilled staff members
- Detail oriented, ability to multitask with strong prioritization, planning and organization skills
- Excellent knowledge of English; verbal and written communication skills

Technical Skills

- Proficiency in Microsoft Office Applications, specifically MS Project and MS Excel
- Robust knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferred
- Programming Languages: C#
- Expert knowledge of Medidata Clinical Cloud (MCC) especially Rave EDC capabilities and best practices
- Familiarity with Clinical Systems and technologies: ePRO, IVRS/IWRS, CTMS
- Experience with Data Reporting Tools: Business Objects, JReview, Cognos, Crystal Reports or related preferred

Skills: medidata , Programming Languages, Ms Office Applications, data reporting, Clinical Systems, Pharmaceutical, Ms Project, Requirement Gathering

Experience: 1.00-4.00 Years

📌 Clinical Database Programmer (Bengaluru)
🏢 eClinical Solutions
📍 Bengaluru