EDC IT Platform Engineer

• 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.

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.
• 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.

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