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Senior Consultant - EDC DevOps Test Engineer

Posted date paź. 01, 2024
Contract type Full time
Job ID R-209909
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Why choose AstraZeneca India?

Help push the boundaries of science to deliver life-changing medicines to patients. After 45 years in India, we’re continuing to secure a future where everyone can access affordable, sustainable, innovative healthcare.

The part you play in our business will be challenging, yet rewarding, requiring you to use your resilient, collaborative and diplomatic skillsets to make connections. The majority of your work will be field based, and will require you to be highly-organised, planning your monthly schedule, attending meetings and calls, as well as writing up reports.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. We empower people like you to push the boundaries of science, challenge convention, and unleash your entrepreneurial spirit. You'll embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Bengaluru or Chennai, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Tech innovators

Make a greater impact through our digitally enabled enterprise. Use your skills in data and technology to transform and optimise our operations, helping us deliver meaningful work that changes lives.

Ownership takers

If you're a self-aware self-starter who craves autonomy, AstraZeneca provides the perfect environment to take ownership and grow. Here, you'll feel empowered to lead and reach excellence at every level — with unrivalled support when you need it.

Challenge seekers

Adapting and advancing our progress means constantly challenging the status quo. In this dynamic environment where everything we do has urgency and focus, you'll have the ability to show up, speak up and confidently take smart risks.

Proactive collaborators

Your unique perspectives make our ambitions and capabilities possible. Our culture of sharing ideas, learning and improving together helps us consistently set the bar higher. As a proactive collaborator, you'll seek out ways to bring people together to achieve their best.

Responsibilities

Job ID R-209909 Date posted 10.01.2024

Job Title: Senior Consultant - EDC DevOps Test 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 a team that supports, manages, and maintains our EDC product and its numerous integration products. Our EDC System is Medidata’s Rave, a GxP compliant part of Clinical Development Platforms used across late science teams in all therapeutic areas. As part of our BizDevOps team, you will work cross-functionally with other team members such as the Product Lead, DevOps Lead, Release Manager, and other technical engineers.

Accountabilities:
AstraZeneca is currently looking for EDC Functional Test Engineer to join our R&D IT: EDC Product Team to help support, manage and maintain our EDC product along with it’s numerous integration products. AZ’s EDC System is Medidata’s Rave, and at AZ is GxP compliant and part of Clinical Development Platforms and is used across late science teams across all therapeutic areas. You will be a part of our BizDevOps team therefore will be responsible to work cross functionally with other team members such as Product Lead, DevOps Lead and Release manager & other technical engineers.

Key Responsibilities:

•Facilitate key discussions with various stakeholders as requested by system

owner/platform lead 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 that happens on the EDC system

•Work with business and perform risk assessment during change implementations/ system upgrades or updates to integrations

•Follow and participate in validation lifecycle for upgrades, changes, & 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

•Responsible to solve day-to-day incidents, service requests and work towards incident-reduction and automation. Also, update Service Now (ticket

management tool) for all events with respect to the incidents, service requests,changes and problems.

• Constantly thrive to learn and upskill according to the organization’s goals anddemands.

•Create Gxp Validation Test cases in Jira Xray for system/upgrade testing

•Perform validation test executions in Jira Xray, for both system testing and regression testing.

• Assist in creating or create UAT test cases that cover the essential business scenarios/use cases for the business.

•Facilitate process requirements gathering: capturing user stories, requirementanalysis, data analysis, programming, database management, and systems integration.

Mandatory Skills

•Extensive experience of using Medidata RAVE UI (Classic or Rave EDC) toperform the following actions:

oStudy build, edit checks programming, deployment to production and migration

oUnderstanding about different roles and permissions in Rave

oUnderstanding of core configuration and clinical views

oUnderstanding of what data extraction capabilities there are

oHands on Experience of Inbound Rave Web Services (eg IVRS or

discrepancy inputs)

oExperience of setting up Rave safety gateway (RSG) and SAE notifications

oExperience of setting up SAS extracts

oExperience on setting up Target Source Data Verification (TSDV)

•Hands on experience of being involved in URL upgrade(s) (Medidata release

updates)

•Knowledge on system validation process / Application Life Cycle Management

•Must have strong communication skills and interpersonal skills

•Responsible to work on technical tasks to keep the Rave URL(s) and it’sintegrations in a maintained state

•Adhere to AZ core ITIL guidelines and perform tasks as incident, change,problem etc.

•Working experience in clinical standard and data collection, clinical data conversion or clinical data programming/testing.

•Understanding of CDASH, SDTM, ADaM CDISC controlled Terminology andFDA/ICH guidelines for clinical study data

•Effective in stakeholder management, translating technical concepts, andworking within team environments.

•Skilled in project management basics and creating clear technicaldocumentation.

Preferred Skills

  • 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

  • Hands-on knowledge in agile management tools like Service NOW

  • Hands-on experience in performing system testing including authoring and executing test cases

  • Passion for learning, innovating, and delivering valuable software to people.

  • Any other programming languages/technical skills e.g: Python, JAVA, etc.

  • Knowledge of other Medidata products and/or Cloud

  • EDC testing (Rave/Inform/Veeva) experience.

Educational Requirements

Bachelor or master’s degree in computer science or life science related discipline with IT/CRO/Pharma experience with total of 8+ years of 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're passionate about patients and committed to constant learning and development. Our work has a direct impact on patients' lives by transforming our ability to develop life-changing medicines. We combine cutting-edge science with leading digital technology platforms and data. Join us at a crucial stage of our journey in becoming a digital and data-led enterprise. Make the impossible possible by building partnerships and ecosystems, creating new ways of working and driving scale and speed to deliver exponential growth.

Are you ready to disrupt an industry and change lives? Apply now to be part of a team that has the backing to innovate, disrupt an industry and change lives.

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.

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Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, safety, empowerment and collaboration. Discover what a career at AstraZeneca could mean for you.

Lifelong learning

Our development opportunities are second to none. You'll have the chance to grow your abilities, skills and knowledge constantly as you accelerate your career. From leadership projects and constructive coaching to overseas talent exchanges and global collaboration programmes, you'll never stand still.

Autonomy and reward

Experience the power of shaping your career how you want to. We are a high-performing learning organisation with autonomy over how we learn. Make big decisions, learn from your mistakes and continue growing — with performance-based rewards as part of the package.

Health and wellbeing

An energised work environment is only possible when our people have a healthy work-life balance and are supported for their individual needs. That's why we have a dedicated team to ensure your physical, financial and psychological wellbeing is a top priority.

Inclusion and diversity

Diversity and inclusion are embedded in everything we do. We're at our best and most creative when drawing on our different views, experiences and strengths. That's why we're committed to creating a workplace where everyone can thrive in a culture of respect, collaboration and innovation.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.