Astrazeneca is currently seeking an edc functional test engineer to join our r&d it: edc product team. The role involves supporting, managing, and maintaining our edc product and its various integrations. Our edc system is medidata’s rave, compliant with gxp standards, and part of clinical development platforms used across late science teams in all therapeutic areas. As part of our bizdevops team, you will collaborate cross-functionally with the product lead, devops lead, release manager, and other technical engineers.
key responsibilities:
1. facilitate discussions with stakeholders, providing sme support on system testing and data integrations.
2. perform impact analysis for system changes.
3. conduct risk assessments during system upgrades and updates.
4. participate in validation lifecycle activities for upgrades and new integrations.
5. develop validation packages following sops.
6. review code and develop solutions for customer requirements, including data extraction methods.
7. participate in business meetings and contribute ideas.
8. manage incidents and service requests, updating servicenow accordingly.
9. engage in continuous learning and skill development.
10. create and execute gxp validation test cases in jira xray.
11. assist in creating uat test cases for business scenarios.
12. gather process requirements, analyze data, and support systems integration.
mandatory skills:
* extensive experience with medidata rave ui or csv computer system validation, including build, edit checks, roles, permissions, and data extraction capabilities.
* hands-on experience with rave web services, rsg, sas extracts, and tsdv setup.
* experience with url upgrades and system validation processes.
* strong communication and interpersonal skills.
* ability to maintain rave urls and integrations, adhering to itil guidelines.
* experience in clinical data collection, conversion, or programming/testing.
* understanding of cdash, sdtm, adam, and fda/ich guidelines.
* proficiency in stakeholder management, technical translation, and technical documentation.
preferred skills:
* experience with sas programming, coder setup, outbound web services, sql scripting, and agile tools like servicenow.
* experience in system testing, automation, and programming languages such as python or java.
* knowledge of other medidata products and cloud technologies.
* experience with edc testing platforms like veeva or inform.
educational requirements:
* bachelor’s or master’s degree in computer science, life sciences, or related fields, with 8+ years of it/cro/pharma experience.
additional information:
strong english communication skills are required. Positions are open to mexican citizens and residents. Location: guadalajara, with a hybrid work model (3 days in-office per week). We promote a flexible working environment.
why astrazeneca?
we embrace change, foster innovation, and aim to build a new kind of organization. Join us to be part of our journey in delivering life-changing medicines.
next steps:
if you're interested, we look forward to hearing from you.
more information:
follow us on linkedin: https://www.linkedin.com/company/1603/
facebook: https://www.facebook.com/astrazenecacareers/
instagram: https://www.instagram.com/astrazeneca_careers/?Hl=en
astrazeneca is an equal opportunity employer, committed to diversity and inclusion.
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