Senior Consultant - EDC Functional Test Engineer

AstraZeneca

AstraZeneca

Quality Assurance
Chennai, Tamil Nadu, India
Posted on Wednesday, August 28, 2024

Job Title - Senior Consultant - EDC Sr. Functional Engineer

Career Level - D2

Introduction to Role:
Join AstraZeneca's R&D IT: EDC Product Team as an EDC Functional Test Engineer. You will be part of our BizDevOps team, working cross-functionally with other team members such as Product Lead, DevOps Lead, Release Manager, and other technical engineers. Our mission is to support, manage, and maintain our EDC product along with its numerous integration products. AZ’s EDC System is Medidata’s Rave, a GxP compliant part of Clinical Development Platforms used across late science teams in all therapeutic areas.

Accountabilities:
As an EDC IT Technology Specialist, you will facilitate key discussions with various stakeholders, provide SME technical support on system testing of the Core EDC Product, and any data integrations. You will perform impact analysis for any changes on the EDC system and work with the business to perform risk assessments during change implementations/system upgrades or updates to integrations. You will also co-develop validation packages in accordance with standard operating procedures (SOPs) and provide support for code review and solutioning for downstream customer requirements.

Essential Skills/Experience:
- Extensive experience of using Medidata RAVE UI
- Hands-on experience of being involved in URL upgrade(s)
- Knowledge of system validation process / Application Life Cycle Management
- Strong communication skills and interpersonal skills
- Working experience in clinical standard 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


- Hands-on Experience of custom function, SAS programming
- Knowledge on Coder / Coder+ setup & 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, stored procedures
- Any other programming languages/technical skills e.g: Python, JAVA, etc.
- EDC testing (Rave/Inform/Veeva) experience.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we are one purpose-led global organisation. We are the enablers and innovators, ensuring that we can fulfil our mission to push the boundaries of science and discover and develop life-changing medicines. We take pride in working close to the cause, opening the locks to save lives, ultimately making a massive difference to the outside world. We dare to lead, applying our problem-solving mindset to identify and tackle opportunities across the whole enterprise. Our spirit of experimentation is lived every day through our events like hackathons. We enable AstraZeneca to perform at its peak by delivering world-class technology and data solutions.

Are you ready to leverage technology to impact patients and ultimately save lives? Apply now and join us in our mission!

Date Posted

28-Aug-2024

Closing Date

12-Sept-2024

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.