At AstraZeneca, patients are at the heart of everything we do.
A global company that pushes the boundaries of science, we all share a big purpose: to discover and develop life-changing medicines that save lives.
We currently have an exciting opportunity for a Senior EDC Technical Specialist with experience in RAVE EDC to join us!
ROLE & RESPONSIBILITIES
- Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on integrations/projects, data extraction from Rave to downstream tools.
- Perform impact analysis for any change that happens on the EDC system
- Work with business and perform risk assessment during change implementations/upgrades
- Oversea the Validation lifecycle for upgrades, changes, & new integrations
- Lead the creation validation packages in accordance with standard operating procedures (SOPs).
- Provide support of code review and solutions for downstream customer requirements, including data extraction methods (SQL, Webservices, APIs)
- Gatekeeper in protecting privacy of patients, and blinding of study data
- Actively participate in business meetings and bring new ideas to the table
- Extensive experience RAVE UI
- Study build and conduct as Data Manager End User
- Understanding about different roles use of Rave
- Understanding on core configuration changes
- Knowledge on RAVE custom reports and custom scripts
- Understanding of data extraction capabilities
- Understanding on URL upgrades (Medidata release updates)
- Knowledge on system validation process / Application Life Cycle Management
- Must have strong communication skills and interpersonal skills
- Must have positive attitude and should be ready to learn new things
- Responsible to work on tasks to maintain RAVE AZ URLs
- Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc.
- Hands on Experience of Rave backend data model, sql script writing, stored procedures
- Hands on Experience of Configurable datasets, Rave WebServices, ODM Adapter, Biostats Adapter
- Knowledge on Rave safety gateway (RSG)
- Knowledge on IRT (IVRS and IWRS) concepts
- Knowledge on Target Source Data Verification (TSDV)
- Hands-on knowledge in tools like HP ALM
- Hands-on experience in performing system testing
- Experience with automation and robotic processing
- Deep knowledge and understanding of Clinical Development would be a significant advantage
AstraZeneca is a place to innovate, take ownership and run with it - with countless opportunities to learn and grow your career. You get to craft your path, but there's support all the way. If this sounds of interest... we would love to hear from you!
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 industry-leading 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 non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.