Skill required: Pharma ERP - SDTM (Study Data Tabulation Model) Mapping
Designation: Management Level - Analyst
Job Location: Mumbai
Qualifications: Bachelor of Pharmacy/Bachelors of Information Technology
Years of Experience: 3-5 years
What would you do?
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 the 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 in setup activities. You will also be developing reports as per design specifications using programming languages like SQL, PLSQL, COGNOS, or SAS.
The SDTM (Study Data Tabulation Model) Mapping team focuses on coordination and management of clinical data standards and production of standard datasets that are submitted as part of a product application to a regulatory authority such (E.g. FDA). The team is responsible for creating and developing standard SDTM diagrams/maps, managing and coordinating the delivery of technical aspects for SDTM mapping of EDC (Electronic Data Capture) trials using the Inform EDC software, Table Trans mapping software, Contivo and related standards and processes.
What are we looking for?
We are looking for individuals who have the following skillset:
- SAS Clinical
- Ability to perform under pressure
- Results orientation
- Ability to work well in a team
- Commitment to quality
- Written and verbal communication
It would be a value add if you are proficient in:
Roles and Responsibilities
- In this role, you are required to analyze and solve lower-complexity problems
- Your day to day interaction is with peers within Accenture before updating supervisors
- You may have limited exposure with clients and/or Accenture management
- You will be given moderate level instructions on daily work tasks and detailed instructions on new assignments
- You will need to be well versed with basic statistics and terms involved in the day to day business and use it while discussing with stakeholders
- You will be expected to constantly be on the lookout for ways to enhance value for your respective stakeholders/clients
- The decisions you make impact your work and may impact the work of others
- You will be an individual contributor as a part of a team, with a focused scope of work.