RAVE Programmer

Project Role: Rave Programmer

Work Experience: 1 years

Work location: Any IQVIA office Location in India

Work Mode: Hybrid

Must Have Skills: Rave, Edit checks

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 1 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