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Position: EDC Developer
Experience: 2 to 12 years
Location: Trivandrum
JOB DESCRIPTION
Objective / Purpose: As the EDC Developer you will work on EDC programming activities and oversee the delivery of EDC databases and documentation to support Takeda Clinical trials implementation and maintenance. You will work with Takeda study teams to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials in EDC.
The EDC Developer will manage EDC system configuration, agile checks, edit checks, programmable protocol deviations, and integrations with EDC.
The EDC Developer operates in compliance with Takeda SOPs and processes while working with Data Management and Standards Teams to enhance existing processes.
The EDC Developer will understand Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts while considering EDC platform best practices.
The EDC Developer will continue developing new skills associated with EDC technologies.
Accountabilities:
• Design, develop and validate clinical trials in EDC
• Manage edit check specifications and configure edit checks at the trial level
• Execute UAT scripts to test the setup of the clinical study or EDC Platforms
• Configure different instances of study (eg: UAT, production, testing etc.,)
• Facilitate user access requests for study teams
• Setup and manage blinded and unblinded study configurations in EDC
• Serve as SME for all EDC database related
📌 EDC Developer (Thiruvananthapuram)
🏢 Tata Consultancy Services
📍 Thiruvananthapuram
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