Senior Consultant

Overview

Senior DevOps test engineer supporting the Medidata Rave EDC product and its integrations within AstraZeneca's R&D IT EDC Product Team, working in a BizDevOps setting.

What you'll do

• Facilitate discussions with stakeholders 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 to the EDC system.
• Work with the business to perform risk assessment during change implementations, system upgrades or updates to integrations.
• Follow and participate in the validation lifecycle for upgrades, changes and new integrations.
• Co-develop validation packages in accordance with standard operating procedures (SOPs).
• Provide support for code review and solutioning for downstream customer requirements, including data extraction methods (SQL, web services, APIs).
• Actively participate in business meetings and bring new ideas to the table.
• Solve day-to-day incidents and service requests, and work towards incident reduction and automation.
• Update Service Now for all events relating to incidents, service requests, changes and problems.
• Learn and upskill in line with organisational goals and demands.
• Create GxP validation test cases in Jira Xray for system and upgrade testing.
• Perform validation test executions in Jira Xray for system and regression testing.
• Assist in creating or create UAT test cases covering essential business scenarios and use cases.

What you'll need

• Extensive experience using Medidata RAVE UI (Classic or Rave EDC) for study build, edit checks programming, deployment to production and migration.
• Understanding of different roles and permissions in Rave.
• Understanding of core configuration and clinical views.
• Understanding of what data extraction capabilities are available.
• Hands-on experience of inbound Rave web services (e.g. IVRS or discrepancy inputs).
• Experience setting up Rave safety gateway (RSG) and SAE notifications.
• Experience setting up SAS extracts.
• Experience setting up Target Source Data Verification (TSDV).
• Hands-on experience being involved in URL upgrade(s) (Medidata release updates).
• Knowledge of system validation process and application lifecycle management.
• Good communication and interpersonal skills.
• Work on technical tasks to keep the Rave URL(s) and its integrations in a maintained state.
• Adhere to AZ core ITIL guidelines and perform tasks such as incident, change and problem management.
• Working experience in clinical standards 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.
• Bachelor's or master's degree in computer science or a life science related field, with IT/CRO/pharma experience and a total of 12+ years of experience.

Nice to have

• Hands-on experience of custom functions and SAS programming.
• Knowledge of Coder / Coder+ setup and 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 and stored procedures.
• Hands-on knowledge of agile management tools such as Service Now.
• Hands-on experience in system testing, including authoring and accomplishing test cases.
• Passion for learning, innovating and delivering valuable software.
• Other programming languages or technical skills, e.g. Python, Java.
• Knowledge of other Medidata products and/or cloud EDC testing (Rave, Inform, Veeva).

Details

• Location: Chennai, India.
• Work on average a minimum of three days per week from the office.