TCS is hiring for Data Engineer
Job Location – Mumbai, Pune, Bangalore,Hyderabad,chennai
Experience Range – 3 to 10 Years
Responsibilities:
As the EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies. You will work with Takeda study team to develop eCRF specifications, build or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Manage and oversee EDC system configuration and dictionaries. Create and own database build SOPs and processes. You will provide consulting services to ensure implementation of technology.
You will work with Data Management and standards teams to implement new processes. You will enhance existing processes for efficient and compliant way of Clinical trial build. The EDC Engineer maintains and serves as an expert for implementation of EDC best practices.
The EDC Engineer would be familiar with leading EDC technologies available on the market. You will continue developing new skills associated with EDC technologies.
Key Accountabilities
- Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process
- Create edit check specifications and program or modify checks at study level within EDC
- Setup different instances of study URL (eg: UAT, production, testing etc.,)
- Setup and configure user accounts for study teams
- Setup and manage blinded and unblinded study configurations
- Be the SME for all database related activities
- Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
- Familiar with custom functions within EDC systems
- Work closely with EDC vendors regarding any tool related issues in the system
- Ability to troubleshoot database setup as per study needs
- Prepare, test and implement post production changes as per study needs
- Archive and retire the study URL after database lock
- Partner with appropriate team members to establish technology standards and governance models
- Establish and support business process SOPs.
- Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
- Be a primary change agent to ensure adoption of new capabilities and business process
