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EDC IT Platform Engineer
1-2 years
Chennai, Bangalore / Bengaluru
1 vacancy
EDC IT Platform Engineer
AstraZeneca
posted 20d ago
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Key skills for the job
Job Description
- Facilitate key discussions with various stakeholders as requested by system owner/platform lead and provide SME technical support on system testing of the Core EDC Product , and any data integrations (in and out) of EDC .
- Perform impact analysis for any change that happens on the EDC system
- Work with business and perform risk assessment during change implementations/ system upgrades or updates to integrations
- Follow and participate in validation lifecycle for upgrades, changes, & new integrations
- Co-develop validation packages in accordance with standard operating procedures (SOPs).
- Provide support of code review and solution ing for downstream customer requirements, including data extraction methods (SQL, Webservices, APIs)
- Actively participate in business meetings and bring new ideas to the table
- Responsible to solve day-to-day incidents, service requests and work towards incident-reduction and automation. Also, update Service Now (ticket management tool) for all events with respect to the incidents, service requests, changes and problems.
- Constantly thrive to learn and upskill according to the organization s goals and demands.
- Create Gxp Validation Test cases in Jira Xray for system/upgrade testing
- Perform validation test executions in Jira Xray , for bot h system testing and regression testing.
- Assist in creating or create UAT test cases that cover the essential business scenarios/use cases for the business .
- Facilitate process requirements gathering: capturing user stories, requirement analysis, data analysis, programming, database management, and systems integration.
- Extensive experience of using Medidata RAVE UI (Classic or Rave EDC) to perform the following actions:
- Study build, edit checks programming, deployment to production and migration
- Understanding about different roles and permissions in Rave
- Understanding of core configuration and clinical views
- Understanding of what data extraction capabilities there are
- Hands on Experience of Inbound Rave Web Services ( eg IVRS or discrepancy inputs)
- Experience of setting up Rave safety gateway (RSG) and SAE notifications
- Experience of setting up SAS extracts
- Experience on setting up Target Source Data Verification (TSDV)
- Hands on experience of being involved in URL upgrade(s) (Medidata release updates)
- Knowledge on system validation process / Application Life Cycle Management
- Must have strong communication skills and interpersonal skills
- Responsible to work on technical tasks to keep the Rave URL(s) and it s integrations in a maintained state
- Adhere to AZ core ITIL guidelines and perform tasks as incident, change, problem etc.
- W orking experience in clinical standard and data collection , clinical data conversion or clinical data programming /testing .
- Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology and FDA/ICH guidelines for clinical study data
- Effective in stakeholder management, translating technical concepts, and working within team environments.
- Skilled in project management basics and creating clear technical documentation.
- Hands on Experience of custom function , SAS programming
- Knowledge on Coder / Coder+ setup & Lab setup
- Hands on Experience of outbound Rave Web Services (ODM Adapter, Biostats Adapter)
- Hands on Experience of Rave backend data model, sql script writing, stored procedures
- Hands-on knowledge in agile management tools like Service NOW
- Hands-on experience in performing system testing including authoring and executing test cases
- Passion for learning, innovating, and delivering valuable software to people.
- Any other programming languages/technical skills e.g : Python, JAVA, etc.
- Knowledge of other Medidata products and/or Cloud
- EDC testing ( Rave/Inform/Veeva) experience.
- Bachelor or master s degree in computer science or life science related discipline with IT/CRO/Pharma experience with total of 8 + years of experience
Employment Type: Full Time, Permanent
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