Job Title: Senior Consultant - EDC DevOps Test Engineer
Career Level - D2
Introduction to role:
Join AstraZeneca's R&D IT: EDC Product Team as an EDC Functional Test Engineer. You will be part of a team that supports, manages, and maintains our EDC product and its numerous integration products. Our EDC System is Medidata’s Rave, a GxP compliant part of Clinical Development Platforms used across late science teams in all therapeutic areas. As part of our BizDevOps team, you will work cross-functionally with other team members such as the Product Lead, DevOps Lead, Release Manager, and other technical engineers.
Accountabilities:
AstraZeneca is currently looking for EDC Functional Test Engineer to join our R&D IT: EDC Product Team to help support, manage and maintain our EDC product along with it’s numerous integration products. AZ’s EDC System is Medidata’s Rave, and at AZ is GxP compliant and part of Clinical Development Platforms and is used across late science teams across all therapeutic areas. You will be a part of our BizDevOps team therefore will be responsible to work cross functionally with other team members such as Product Lead, DevOps Lead and Release manager & other technical engineers.
Key Responsibilities:
•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 solutioning 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 anddemands.
•Create Gxp Validation Test cases in Jira Xray for system/upgrade testing
•Perform validation test executions in Jira Xray, for both 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, requirementanalysis, data analysis, programming, database management, and systems integration.
Mandatory Skills
•Extensive experience of using Medidata RAVE UI (Classic or Rave EDC) toperform the following actions:
oStudy build, edit checks programming, deployment to production and migration
oUnderstanding about different roles and permissions in Rave
oUnderstanding of core configuration and clinical views
oUnderstanding of what data extraction capabilities there are
oHands on Experience of Inbound Rave Web Services (eg IVRS or
discrepancy inputs)
oExperience of setting up Rave safety gateway (RSG) and SAE notifications
oExperience of setting up SAS extracts
oExperience 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’sintegrations in a maintained state
•Adhere to AZ core ITIL guidelines and perform tasks as incident, change,problem etc.
•Working experience in clinical standard and data collection, clinical data conversion or clinical data programming/testing.
•Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology andFDA/ICH guidelines for clinical study data
•Effective in stakeholder management, translating technical concepts, andworking within team environments.
•Skilled in project management basics and creating clear technicaldocumentation.
Preferred Skills
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.
Educational Requirements
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
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're passionate about patients and committed to constant learning and development. Our work has a direct impact on patients' lives by transforming our ability to develop life-changing medicines. We combine cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Make the impossible possible by building partnerships and ecosystems, creating new ways of working and driving scale and speed to deliver exponential growth.
Are you ready to disrupt an industry and change lives? Apply now to be part of a team that has the backing to innovate, disrupt an industry and change lives.
Date Posted
Closing Date
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.