You will be aligned with our Pharmaceuticals Processes vertical and help us with the processes to collect, monitor, research, assess and evaluate information on the adverse effects of medication with a view to identifying new information about hazards associated with medicines and consequently, prevent harm to patients. It also deals with the reviewing and resolving of discrepancies identified by the system or through manual checks as per guidelines. Employees under this span can also be responsible for a number of activities related to the design, development, and maintenance of Clinical Database objects.
You will be working as a part of Pharma ERP team which is responsible for a number of activities related to the design, development, and maintenance of clinical database objects. Maintenance of case report forms, database objects, forms, edit checks and procedures. Will develop Study Data Tabulation Model (SDTM)) solutions and work on the end to end ma in setup activities. Develop reports as per design specifications using programming languages like SQL, PLSQL, COGNOS or SAS.
You will be responsible for SDTM - Study Data Tabulation Module where in you will develop Study Data Tabulation Model (SDTM) solutions and work on end to end mapping of setup activities while also developing standard productized SDTM diagrams/maps. You will be required to manage and coordinate the delivery of technical aspects for SDTM mapping of EDC trials using the Inform EDC software, Table Trans mapping software, Contivo and related standards and processes.
Roles and Responsibilities
In this role you are required to solve routine problems, largely through pre cedent and referral to general guidelines. Expected interaction is within own team and direct supervisor. Detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments would be provided. Decisions impact own work. Individual contributor as a part of a team, with a predetermined, focused scope of work.