Client: Otsuka America Pharmaceuticals Inc
Roles and responsibilities:
- Work closely with Technical & Business stakeholders to align with Business strategies, objectives and Roadmaps and plan for the necessary deliverables.
- Continuously involved in the improvement of existing applications and a mandatory member for any next-gen architectural discussion.
- Worked on various roles in multiple tracks of Clinical process which includes Clinical Data management systems(CDMS), Risk Based Monitoring(RBM), Project server, and Technical Operations.
Clinical Data management systems(CDMS)
- Worked on Base SAS operations(import, export, PROC compare), ingestion of SDTM/CDASH SAS datasets into Clinical database using Clintrial and OASIS tool, exposed to operations with Oracle LSH and its integration with Argus Safety tool for reconciliation.
- Involved in XPT to sas format conversion, Coding the verbatim terms to global clinical terms using various universal Medical dictionaries such as MedDRA and WHODRUG though dsNavigator and Eclipse tool.
Project Server
- Responsible for creation and maintenance of reports and views in MSBI(SSRS) and Qlikview.
- Responsible for all Qlikview admin activities and accomplished in-house migration of Qlikview server.
Technical Operations
- Responsible for Business process support for Mystic Ensur(Specification management system) and Global Vision-Document proofing system
ePlatform
- Responsible for ETL operations of variety of data received from multiple Clinical vendors(eSource/EDC, eConsent, CRO, Labs, ECG) through Python and Cloudera Hadoop components.
- Architected an unified Master database model for RBM reporting and involved in multiple performance improvement activities.
- Created CDASH datasets from Raw data for a specific vendor and delivered it clinical data management team for TLS and SDTM conversion.
- Responsible for creation and maintenance of Tableau Dashboard based on User requirements.
- Involved in Proof of concepts related to AWS Cloud migration of the Platform, analysis of Snowflake and EMR for the next gen cloud solutions.
Tech Stack: CDH5/6, Hadoop2/3, Hive, Impala, SQOOP, Python2/3, Tableau 10.0/2019, Qlikview 11/12, Excel VBA Macro, Base SAS, VBScript
