Senior Consultant
AstraZeneca (company site, opens in a new tab)12+ yrsChennaiOn-siteDirect career pageEst. 22–35 LPA
Posted 2d ago
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Job description
Structured overview of role & requirements
About This Role
- Provide SME technical support and perform testing for Medidata Rave EDC core product and integrations, including validation and impact analysis of system changes.
- Manage and maintain Rave URL(s) and integrations, handle incidents, service requests, and assist in automation to reduce incidents.
- Create and execute GxP validation and UAT test cases using Jira Xray, collaborating with cross-functional teams including Product Lead, DevOps Lead, and Release Manager.
Minimum Requirements
- Extensive hands-on experience with Medidata RAVE UI covering build, edit checks, deployment, permissions, and data extraction capabilities.
- Bachelor's or master's degree in computer science or life sciences with IT/CRO/Pharma background; 12+ years total experience.
- Knowledge of system validation processes, application lifecycle management, and clinical study data standards such as CDASH, SDTM, ADaM, CDISC controlled terminology, and FDA/ICH guidelines.
- Experience working with ITIL guidelines and tools such as Service Now for incident, change, and problem management.
Ideal Candidate Profile
- Experienced in clinical data collection and programming/testing within regulated clinical development environments using Medidata Rave EDC and related integrations.
- Operational focus on EDC system testing, validation lifecycle, and cross-functional collaboration with technical and business stakeholders.
- Senior-level technical contributor familiar with GxP compliance and capable of independently managing complex testing, validation, and incident resolution tasks in a regulated pharma IT context.