Clinical Database Programmer

2 days ago

bangalore, India eClinical Solutions Full time

Clinical Database Programmers are operationally responsible to provide technical support and oversight for the Medidata Clinical Cloud (MCC) implementation activities. Clinical Database Programmers will maintain project level perspective, focus and communicate effectively as the MCC SME on technical and functional electronic data capture programming and data management activities, timelines and deliverables. 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 reportsPerforms peer review for the studies built by other Clinical Database ProgrammersResponsible 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 modulesManages 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 functionalityWorking knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, iMedidata/Cloud Admin or other modules.Other duties as assigned CANDIDATE'S PROFILEEducation & ExperienceBachelor's degree or equivalent work experience preferred2+ years in Pharmaceutical/Biotechnology industry or equivalent preferredExperience with requirements gathering, design and specification development of CRFs, edit checks, site queries, and understanding of database structures and programming languages Professional SkillsAbility to work creatively and independently to carry out assignments of a complex natureAbility to communicate and work effectively and cooperatively with other professional staff membersDetail oriented, ability to multitask with strong prioritization, planning and organization skillsExcellent knowledge of English; verbal and written communication skills Technical Skills Proficiency in Microsoft Office Applications, specifically MS Project and MS ExcelStrong knowledge of ICH/GCP guidelines, 21 CFR Part 11 and clinical trial methodology preferredProgramming Languages: C#Expert knowledge of Medidata Clinical Cloud (MCC) especially Rave EDC capabilities and best practicesFamiliarity with Clinical Systems and technologies: ePRO, IVRS/IWRS, CTMSExperience with Data Reporting Tools: Business Objects, JReview, Cognos, Crystal Reports or related preferred

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