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AstraZeneca

Global pharmaceutical company developing prescription medicines

Senior DevOps Test Engineer for EDC

Manual & Functional QAPosted on Nov 10
Full-timeChennai, Tamil Nadu, IndiaNo salary listed

About the Job

Requirements

  • Extensive experience using the Medidata Rave user interface (Classic or Rave EDC) for study builds, edit-check programming, production deployment, and migration.
  • Understanding of roles and permissions in Rave, core configuration, clinical views, and data-extraction capabilities.
  • Hands-on experience with inbound Rave web services, such as IVRS or discrepancy inputs.
  • Experience setting up the Rave Safety Gateway and serious adverse event notifications.
  • Experience setting up SAS extracts and Target Source Data Verification.
  • Hands-on experience participating in Medidata release URL upgrades.
  • Knowledge of system validation processes and application lifecycle management.
  • Experience working on technical tasks to maintain Rave URLs and integrations.
  • Ability to follow ITIL guidelines and perform incident, change, and problem-management tasks.
  • 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.
  • A bachelor's or master's degree in computer science or a life-science-related field, with IT/CRO/pharma experience and 12 or more years of total experience.

Responsibilities

  • Facilitate stakeholder discussions as requested by the system owner or platform lead and provide subject-matter-expert technical support for testing the core EDC product and its inbound and outbound data integrations.
  • Perform impact analyses for changes to the EDC system.
  • Work with the business to perform risk assessments during change implementations, system upgrades, and integration updates.
  • Follow and participate in the validation lifecycle for upgrades, changes, and new integrations.
  • Co-develop validation packages in accordance with standard operating procedures.
  • Support code reviews and solutioning for downstream customer requirements, including data-extraction methods using SQL, web services, and APIs.
  • Participate in business meetings and contribute ideas.
  • Resolve day-to-day incidents and service requests, work to reduce incidents and automate tasks, and update ServiceNow for incidents, service requests, changes, and problems.
  • Create GxP validation test cases in Jira Xray for system and upgrade testing.
  • Execute validation tests in Jira Xray for system and regression testing.
  • Assist with or create user acceptance testing cases covering essential business scenarios and use cases.

Desired Qualifications

  • Hands-on experience with custom functions and SAS programming.
  • Knowledge of Coder/Coder+ and lab setup.
  • Hands-on experience with outbound Rave web services, including ODM Adapter and Biostats Adapter.
  • Hands-on experience with the Rave backend data model, SQL script writing, and stored procedures.
  • Hands-on knowledge of agile management tools such as ServiceNow.
  • Hands-on experience performing system testing, including authoring and completing test cases.
  • Knowledge of other programming languages or technical skills, such as Python and Java.
  • Knowledge of other Medidata products or cloud technologies.
  • EDC testing experience with Rave, Inform, or Veeva.

About the Company

AstraZeneca

Global pharmaceutical company developing prescription medicines

AstraZeneca develops and markets prescription medicines and vaccines worldwide, with a focus on oncology, cardiovascular/metabolic, respiratory, and infectious diseases. Its products work by targeting specific biological pathways or cells, using small-molecule therapies, biologics, and vaccines to treat diseases or prevent infections. It differentiates itself through its dual heritage from Sweden and the UK, a broad pipeline, and strong R&D and collaborations that move from discovery to patient access. Its goal is to improve people’s health by discovering, developing, and delivering medicines and vaccines to patients worldwide.

Company size
10,001+
Company stage
IPO
Headquarters
Cambridge, United Kingdom
Founded
1913

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