PR
Systems Validation Analyst II
full-time•India
About this role
Premier Research is looking for a Systems Validation Analyst II to join our IT & Corporate Administration team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
The Systems Validation Analyst II performs business analysis, systems validation, and testing processes required to support the software development and implementation processes for both regulated and non-regulated systems. Responsibilities include working closely with business subject matter experts to define and document requirements and business processes that drive the features in the software used to support various segments of the clinical trials process. This position also directs validation/user acceptance testing ensuring final outcomes meet specified requirements. Lastly, this position ensures and facilitates corporate compliance with applicable regulations as they affect software development, implementation, and maintenance in a regulated environment. This includes participation in customer audits (e.g., supporting documentation requests).
Work with users, developers, administrators to develop/assist in the development of: User requirements/design/functional specifications, system test plans/test scripts; assist users in the execution and documentation of test scripts
Participate in ongoing operational/risk assessment activities such as change management, admin/maintenance reviews/monitoring, periodic reviews, etc.
Research, develop, and write content for the validation/UAT of software products and services
Act as an independent quality reviewer for peer and/or vendor created documentation
Must be able to work part of U.S. Eastern Time until around 12pm
What you'll do
- The Systems Validation Analyst II performs business analysis, systems validation, and testing processes to support software development and implementation. This includes directing validation/user acceptance testing and ensuring compliance with applicable regulations.
About Premier Research
Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.
Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.
Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval.
Through our commitment to partner boldly, deliver impact, and foster community, we’re driving change that advances research and improves lives while creating meaningful opportunity for patients, customers, and all Premier team members. Follow our page to learn more about our work—and explore career opportunities to be part of the transformation.
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Frequently Asked Questions
What does a Systems Validation Analyst II do at Premier Research?
As a Systems Validation Analyst II at Premier Research, you will: the Systems Validation Analyst II performs business analysis, systems validation, and testing processes to support software development and implementation. This includes directing validation/user acceptance testing and ensuring compliance with applicable regulations..
Is the Systems Validation Analyst II position at Premier Research remote?
The Systems Validation Analyst II position at Premier Research is based in India, India. Contact the company through Clera for specific work arrangement details.
How do I apply for the Systems Validation Analyst II position at Premier Research?
You can apply for the Systems Validation Analyst II position at Premier Researchdirectly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.