Clinical Database Programmer(CF)

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 professional 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


• Strong 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