Rave Programmer

• 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.

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.

Bachelor s degree, or educational equivalence, in computer/life science or related field; or equivalent combination of

Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.