Kolkata, India | Full time | Hybrid | R1549292

Join global organization with 82000+ employees around the world, as Senior Database Management Specialist.

RESPONSIBILITIES
- Plan and coordinate database design, development, implementation, maintenance, and user support of clinical systems with guidance from senior staff.
- Building current 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

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