Job Description

RESPONSIBILITIES Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems with guidance from senior staff. Building new modules and maintaining global libraries for clinical trials. Working alongside Data Management to modify existing modules Management of a global library for a large number of projects. Good Knowledge of Data Clinical Standards, Data Models and its implementation for database and GLIB development Identifying and resolving issues which may negatively impact delivery of global library objects. Escalating issues to leadership as needed. Building, maintaining and documenting the global library objects in order to facilitate the creation of Study Level databases to collect clinical trial data. Working with the Data Managers - Study Start Up and Database Developers to implement new or modified global library objects. Work with other global librarians (GL) to understand the data requirements for collection and submission under general supervision. Support more experienced GL with the creation of metadata specifications that define the data content and structures for collection, transformation, and CDISC SDTM submission requirements, with general direction. Contribute to the review of global SOPs and business guidance/user guides directly impacting the function and providing input when applicable. Document, develop, test and maintain CDMS validations and derivations procedures using (SQL, PL/SQL, C #, VB script, SAS). With general direction, work with the Data Standards Governance team, other GL s and/or members of the metadata team to discuss technical issues with implementation of approved collection SDTM data structures With general direction, develop, and test all new Global/Disease level Library objects needed for clinical studies in a provisional state or equivalent in CDMS. With general direction, document, develop, review, and maintain Global Library Copy Groups for reuse of standard pages for individual trials. Recommend newly discovered practices for consideration towards the maintenance of the Global Library Conventions document for data modeling/standards and Style Guide for CDMS implementation. REQUIRED KNOWLEDGE, SKILLS AND ABILITIES Minimum 2 years clinical database programming, setup of clinical databases and CRF design experience gained in the pharmaceutical industry or CRO as well as the following: Basic CDISC Understanding: Implementation of CDISC Standards. In depth experience with RAVE (Rave certified), Global Library maintenance and procedure building including custom function programming. Good Understanding of clinical data management systems and/or relational databases as applied to clinical trials: Input to requirements for eCRF Development. Preferable knowledge of Development of validation and derivation procedures. Preferable to have any scripting language experience. Attention to detail, quality, time management and customer focus Ability to translate technical concepts for nontechnical users in the areas of CRF and validation procedure implementation in CDMS. MINIMUM REQUIRED EDUCATION AND EXPERIENCE Bachelor s degree, or educational equivalence, in computer/life science or related field; or equivalent combination of education, training, and experience