KEY TASKS & RESPONSIBILITIES

 Read and understand clinical study protocols to better understand the programming needs for a specific trial

 Develop and build basic components of clinical databases, including forms and structure, data dictionaries and unit dictionaries

 Program a range of simple to complex validations to support validation of the clinical data

 Collaborate with cross-functional team members (i.e. Data Managers, Biostatisticians, Coders, etc)

and clients to review the business requirements and translate them into database objects and visualizations

 Design, develop, test, and deploy highly productive SQL code and data mapping code according to specifications

 Develop and support rigorous QC processes to ensure quality of data deliverables.

 Develop ETL code in support of analytic software applications and related analysis projects

 Build any analytics reports and visualizations using tools like JReview, Qlik

 Provide diagnostic support and fix defects as needed

 Ensure compliance with eClinical Solutions/industry quality standards, regulations, guidelines, and procedures

 Other duties as assigned

CANDIDATE'S PROFILE

Education & Experience

 Bachelor's degree and/or equivalent work experience preferred

 5+ years in Pharmaceutical/Biotechnology industry or equivalent preferred

Position: Clinical Database Programmer

 Familiarity with EDC Systems: Rave, InForm, or Veeva preferred; previous experience designing eCRFs and edit checks

 Knowledge of clinical trial data is a plus - CDISC ODM, SDTM,



or ADAM standards

 Experience developing back end, database/warehouse architecture, design and development preferred

 Knowledge of variety of data platforms including SQL Server, DB2, Teradata, (Cloud based DB a plus)

Professional Skills

 Detail oriented, ability to multitask with strong prioritization, planning and organization skills

 Excellent knowledge of English; verbal and written communication skills

 Proficiency in clinical protocol interpretation and application

 Excellent team player

 Good understanding of technical challenges and capability to analyze requirement and technical problems

 Excited to learn new tools and product modules and adapt to changing technology and requirements

Technical Skills

 Proficiency in Microsoft Office 365 Suite including Excel, Word, and Outlook

 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 and industry standards (CDASH, SDTM) preferred

 Familiarity and/or proficiency with database platforms

 Preferred experience in object-oriented programming languages and concepts (i.e. SQL, T-SQL,

PL/SQL, C#)

 Familiarity with Data Reporting Tools: QlikSense, QlikView, Spotfire, Tableau, JReview, Business

Objects, Cognos, MicroStrategy, IBM DataStage, Informatica, Spark or related

📌 Clinical Database Programmer (Bengaluru)
🏢 Trigent Software
📍 Bengaluru