Prin IT Technologist - Clinical Research Technology Specialist (EDC, eCOA & eConsent)

IND-Medtronic MiniMed India Private Limited; Pune District; On-site; INR 2,200,000 - 3,800,000; Full time

Job summary

Medtronic MiniMed India Private Limited in Pune leads the global diabetes capability expansion, focusing on innovative solutions for diabetes management. The role covers configuring and validating EDC platforms, collaborating with data management to design CRFs, and ensuring regulatory alignment across global and regional requirements.

The specialist will oversee validation activities (IQ/OQ/PQ), support data integrity during database locks, and partner with clinical, regulatory, and IT teams

Qualifications

• 7+ years of experience in clinical data management.
• Experience with EDC platforms and regulatory standards (CDASH/CDISC).
• Bachelor’s degree in life sciences or related field.

Responsibilities

• Lead configuration, validation, and deployment of EDC platforms.
• Collaborate with data management to design CRFs aligned to protocol and CDASH/CDISC.
• Oversee IQ/OQ/PQ validation and maintain documentation.
• Support database lock activities and ensure audit-ready data integrity.
• Work with clinical and regulatory teams for linguistic validation and endpoint alignment.

Skills

Project leadership

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree or higher in life sciences

Tools

Medidata Rave

Veeva Vault EDC

Oracle Clin One

REDCap

Job description

About the Role

A Day in the Life Our Global Diabetes Capability Center in Pune is expanding to serve more people living with diabetes globally. Our state-of-the-art facility is dedicated to transforming diabetes management through innovative solutions and Technologies that reduce the burden of living with diabetes. This position is an exciting opportunity to work with Minimed’s Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. #BetterDaysStartNow

Responsibilities

• Lead configuration, validation, and deployment of EDC platforms (e.g., Medidata Rave, Veeva Vault EDC, Oracle Clinical One, REDCap), eCOA, eConsent, coder
• Collaborate with data management teams to design CRFs (Case Report Forms) aligned to protocol requirements and CDASH/CDISC standards
• Oversee system validation activities including IQ/OQ/PQ and maintain associated documentation
• Support database lock activities and ensure audit-ready data integrity
• Work with clinical and regulatory teams to ensure linguistic validation and endpoint alignment
• Ensure system and process meet applicable global and regional regulatory requirements
• Manage integration between EDC, ePRO, eConsent, and broader clinical ecosystem (CTMS, randomization/IXRS, safety systems)
• Develop and maintain SOPs, work instructions, and governance documentation for all platforms
• Lead vendor management activities including contract oversight, SLA monitoring, and escalation management
• Ensure all systems comply with 21 CFR Part 11, GDPR, HIPAA, and ISO 14155 (for medical device trials)
• Partner with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, and IT teams
• Provide training and change management support to internal teams and investigative sites
• Act as the primary point of contact for CROs and technology vendors
• Present system status, risk assessments, and metrics to senior leadership

Specialist Career Stream

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Differentiating Factors

• Autonomy: Recognized expert, managing large projects or processes. Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager. Coaches, reviews and delegates work to lower level specialists.
• Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results. May manage large projects or processes that span outside of immediate job area.
• Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation. Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area. Implements solutions to problems.
• Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making.
• Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area. Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.

Required Knowledge and Experience

Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. May have broad knowledge of project management. 7+ years of experience with a bachelor’s degree or 5+ years of experience with an advanced degree or 12+ years of experience with a high school diploma or equivalent.

Physical Job Requirements

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.

Benefits & Compensation

• MiniMed offers a competitive salary and flexible benefits package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.

MiniMed is a full-stack insulin delivery company dedicated to supporting people living with diabetes through every step of their journey — when and how they need it. With a heritage rooted in technology, empathy, and a relentless pursuit of innovation, we’re focused on one thing: making every day a better day for people with diabetes. From our intelligent dosing systems that stay one step ahead to our always-on support when it’s needed most, we’re committed to building a connected system of care that works together and fits into everyday life, so people with diabetes can move through the day with fewer interruptions. Fewer second guesses. And more freedom to live in the moment. We’re here to make better days possible for people with diabetes. Joyful, messy, fully lived days. Days where things feel lighter, easier.

For more than four decades, we’ve been driven by this mission, delivering groundbreaking advancements in technology to help people live more fully, freely, and with greater confidence. At MiniMed, diabetes care is personal for us. Many of our employees have a connection to diabetes, whether they're living with it themselves or through family members and friends, and we all show up each day to help make the lives of our coworkers and loved ones easier. Our people-first priority. At MiniMed, we put our customers at the forefront of all we do, and that focus extends to our team as well. We're dedicated to creating a culture of belonging and providing our people with all the career-building resources you might need. Our life-transforming technologies. No matter what your role at our company, you're making a difference in the lives of people with diabetes. Our innovative inventions improve their day-to-day by helping lift the mental load and allowing diabetes to fade into the background, empowering them to live life on their own terms.

Our focus on the future. We're chasing the dream of a world where people with diabetes can be free of that never-ending battle of balancing blood sugar. A world where better days are the norm, not the exception. Fresh faces and new viewpoints will help create our cutting-edge solutions and define the next generation of breakthroughs in care, so that a better day can start today.

Equal Employment Opportunity

It is the policy of MiniMed 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, MiniMed 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.