EDC IT Platform Engineer

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. You'll play a crucial role in managing, improving, and maintaining our EDC product, Medidata’s Rave, which is GxP compliant and integral to our Clinical Development Platforms. Collaborate with multi-functional 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.
• Co-develop validation packages following standard operating procedures.
• Create and complete GxP Validation Test cases in Jira Xray for system and regression testing.
• Resolve day-to-day 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.
• Hands-on 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 life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're 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 purpose-led, pushing the boundaries of science to discover life-changing 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 data-led 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!