EDC IT Platform Engineer AstraZeneca India

8.0 - 12.0 years

0 Lacs

karnataka

On-site

As an EDC IT Platform Engineer at AstraZeneca, you will join the R&D IT: EDC Product Team to provide support, manage, and maintain the EDC product, including various integration products. AstraZeneca's EDC System is Medidata's Rave, which is GxP compliant and a crucial part of Clinical Development Platforms used across late science teams in all therapeutic areas. Your key responsibilities will include facilitating discussions with stakeholders, providing SME technical support on system testing of the Core EDC Product and data integrations, performing impact analysis for system changes, conducting risk assessments during change implementations, following the validation lifecycle for upgrades and new integrations, and co-developing validation packages according to SOPs. Additionally, you will be involved in code review, solutioning for downstream customer requirements, participating in business meetings, handling day-to-day incidents and service requests, working towards incident reduction and automation, updating Service Now for events, creating GxP Validation Test cases in Jira Xray, executing validation tests, creating UAT test cases, and facilitating process requirements gathering. Mandatory skills for this role include extensive experience with Medidata RAVE UI, understanding of core configuration and clinical views, knowledge of data extraction capabilities, hands-on experience with Inbound Rave Web Services, SAS extracts, TSDV, and setting up Rave safety gateway and SAE notifications. You must also have expertise in system validation, strong communication and interpersonal skills, and adherence to ITIL guidelines. Preferred skills include hands-on experience with custom functions, SAS programming, Coder/Coder+ setup, outbound Rave Web Services, Rave backend data model, SQL script writing, and agile management tools. Knowledge of other programming languages, technical skills, and EDC testing experience is a plus. To qualify for this role, you should have a Bachelor's or Master's degree in computer science or a life science-related discipline with IT/CRO/Pharma experience and a total of 8+ years of experience. Join us at AstraZeneca to contribute to our innovative projects and grow your skills in a collaborative environment.,

Posted 1 day ago

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