drjobs EDC IT Platform Engineer

EDC IT Platform Engineer

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1 Vacancy
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Job Location drjobs

Chennai - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Job Title EDC IT Platform Engineer

Career Level D1

Introduction to role

Are you ready to make a difference in the world of medicine AstraZeneca is seeking an EDC IT Platform Engineer to join our R&D IT: EDC Product Engineering Team. Youll play a crucial role in managing improving and maintaining our EDC product Medidatas Rave which is GxP compliant and integral to our Clinical Development Platforms. Collaborate with multifunctional teams including IT Product Leads DevOps Leads and business teams to support the EDC Product across all therapeutic areas.

Accountabilities

  • Facilitate key discussions with partners and provide SME technical support on system improvements and testing of the Core EDC Product and data integration tools.
  • Participate in the validation lifecycle for upgrades changes and new integrations.
  • Perform risk assessments during change implementations and system upgrades.
  • Conduct impact analysis for changes on the EDC system.
  • Support code review and solutioning for downstream customer requirements including data extraction methods.
  • Codevelop validation packages following standard operating procedures.
  • Create and complete GxP Validation Test cases in Jira Xray for system and regression testing.
  • Resolve daytoday incidents and service requests aiming for incident reduction and automation.
  • Facilitate process requirements gathering and adhere to AZ core ITIL guidelines.
  • Maintain the Rave URL(s) and its integrations.

Essential Skills/Experience

  • Extensive experience using Medidata RAVE UI (Classic or Rave EDC) for study build edit checks programming deployment and migration.
  • Understanding of core configuration clinical views roles permissions and data extraction capabilities/tools in Rave.
  • Handson experience with Inbound Rave Web Services Rave safety gateway setup SAS extracts and Target Source Data Verification (TSDV).
  • Experience with URL upgrades (Medidata release notes review and upgrades).
  • Knowledge of system validation processes and Application Life Cycle Management.
  • Experience in clinical standards data collection conversion or programming/testing.
  • Understanding of CDASH SDTM ADaM CDISC controlled Terminology and FDA/ICH guidelines.
  • Effective partner management and communication skills.

Desirable Skills/Experience

  • Experience with custom functions SAS programming Coder/Coder setup Lab setup.
  • Experience with outbound Rave Web Services and Rave backend data model.
  • Knowledge of agile management tools like Service NOW.
  • Experience in system testing including authoring and implementing test cases.
  • Passion for learning and delivering valuable software.
  • Knowledge of other Medidata products and/or Cloud.
  • EDC testing experience (Rave/Inform/Veeva).

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire lifechanging medicines. Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca we leverage technology to impact patients lives directly. Our global organization is purposeled pushing the boundaries of science to discover lifechanging medicines. We empower our teams to innovate with ground breaking technology platforms and data analytics. Join us at this pivotal stage as we transform into a digital and dataled enterprise. Here you can explore new solutions in a dynamic environment that encourages lifelong learning and innovation.

Ready to take on this exciting challenge Apply now to be part of our journey!

Date Posted

15May2025

Closing Date

29Jun2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industryleading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.

Employment Type

Full-Time

Company Industry

About Company

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