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Medtronic plc is seeking a Lead Tester for clinical database testing, focusing on QA of electronic data capture systems and study workflows. This remote India-based role requires hands-on experience with Medidata Rave and a strong background in GCP compliance and validation activities.
You will develop test plans, execute test scripts, coordinate UAT with study teams, and ensure defect fixes are verified and documented in accordance with regulatory standards.
Remote
Bangalore , Karnataka, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
Full time
R80897
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
This role supports the clinical data management function responsible for the testing and validation of clinical study databases used in global clinical research. The team partners with clinical data management, programming, study teams, and business stakeholders to ensure electronic data capture systems are configured, tested, and validated in accordance with study requirements, standard operating procedures, and regulatory expectations.
This is a remote position based in India with no travel requirements. The role focuses on quality assurance activities supporting clinical database development, user acceptance testing, and ongoing process improvements across clinical studies.
The Lead Tester is responsible for testing and validating clinical study databases, electronic case report forms, edit checks, integrations, and study workflows. This role works closely with study teams and stakeholders to ensure systems meet protocol requirements, support user acceptance testing activities, and maintain compliance with Good Clinical Practice and regulatory standards. The position requires hands‑on experience with Medidata Rave and clinical database testing processes.
Responsibilities may include the following and other duties may be assigned.
Review study protocols, specifications, electronic Case Report Form (eCRF) design documents, and related study documentation to understand system requirements.
Develop and execute test plans, test cases, and test scripts for clinical database validation activities.
Perform functional testing of electronic Case Report Forms, edit checks, integrations, and study workflows.
Validate simple and complex edit checks to ensure accurate system functionality and data quality.
Identify, document, track, and verify defects through established issue management processes.
Coordinate and support User Acceptance Testing activities with study teams and business stakeholders.
Validate defect fixes and confirm successful resolution of issues identified during testing cycles.
Maintain testing documentation and ensure compliance with Good Clinical Practice, standard operating procedures, and applicable regulatory requirements.
Experience with Medidata Rave Classic and/or Medidata Rave EDC.
Experience developing and executing test plans, test cases, and test scripts for clinical systems.
Experience performing User Acceptance Testing and defect management activities.
Knowledge of Good Clinical Practice, clinical trial processes, and clinical data management standards.
Experience testing clinical databases supporting global clinical studies.
Experience validating complex edit checks, integrations, and study workflows.
Experience working with clinical data management and cross‑functional study teams.
Experience supporting audit readiness and regulated testing documentation.
Experience contributing to process improvement and quality initiatives within clinical research environments.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP).
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life‑long learning
These commitments set our team apart from the rest:
Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career‑building resources you need.
No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Fresh viewpoints. Cutting‑edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare settingis considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E‑Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E‑Verify program, please click here (https://www.e‑verify.gov/employees) .