Job Title - EDC IT Platform Engineer 

Career Level - D1

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 and demands. 

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, requirement analysis, data analysis, programming, database management, and systems integration. 

Mandatory Skills 

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. 

Working 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. 

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 

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.