Senior Consultant

Overview

Senior DevOps Test Engineer supporting the EDC product team, responsible for functional testing, validation and maintenance of AstraZeneca's Medidata Rave EDC system and its integrations.

What you'll do

• Facilitate key 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 business and 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 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.
• Solve day-to-day incidents and service requests, work towards incident reduction and automation, and update Service Now for all events.
• Learn and upskill according to the organization's 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 there are.
• Hands-on experience of inbound Rave Web Services (e.g. 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 of system validation process and Application Life Cycle Management.
• Good communication and interpersonal skills.
• Responsible for 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 life science related field with IT/CRO/Pharma experience, with 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 performing 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) experience.

Details

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