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 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