Job Description

Skill required: Pharma ERP - SDTM (Study Data Tabulation Model) Mapping

Designation: Team Lead/Consultant

Job Location: Bengaluru

Qualifications: BCA/BE/BTech

Years of Experience: 7-11 years

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com

  

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:

  • Adaptable and flexible
  • Ability to perform under pressure
  • Problem-solving skills

It would be a value add if you are proficient in:

  • SDTM Programming

Roles and Responsibilities

  • In this role, you need to analyze and solve moderately complex problems
  • You are required to create new solutions, leveraging and, where needed, adapting existing methods and procedures
  • You are required to understand the strategic direction set by senior management, clearly communicate team goals, deliverables, and keep the team updated on change
  • Your primary upward interactions are with your direct supervisor
  • You may interact with peers and/or management levels at a client and/or within Accenture
  • You will be provided with guidance when determining methods and procedures on new assignments
  • The decisions that are made by you will often impact your team
  • You would be an individual contributor and/or oversee a small work effort and/or team.

Please note this role may require you to work in rotational shifts.



Qualifications

BCA/BE/BTech

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Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.

Accenture is committed to providing veteran employment opportunities to our service men and women.

COVID-19 update:  The safety and well-being of our candidates, our people and their families continues to be a top priority. Until travel restrictions change, interviews will continue to be conducted virtually. 

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