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

USA-MiniMed Distribution Corp. 1018; Pune District; Presencial; INR 1.800.000 - 3.000.000; Jornada completa

Descripción de la vacante

MiniMed in Pune is expanding its Global Diabetes capability center to transform diabetes management through innovative EDC platforms and integrated data systems.

The role leads configuration, validation, and deployment of platforms like Medidata Rave, Veeva Vault EDC, Oracle Clinical One, and REDCap, while aligning CRFs to CDISC standards and ensuring regulatory compliance across 21 CFR Part 11, GDPR, and HIPAA.

Formación

• Requires mastery of a specialty area and full knowledge of industry practices.
• 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+.

Responsabilidades

• Lead configuration, validation, and deployment of EDC platforms.
• Collaborate with data management teams to design CRFs aligned to standards.
• Oversee system validation activities including IQ/OQ/PQ.
• 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.
• Develop and maintain SOPs, work instructions, and governance documentation.
• Lead vendor management activities including contract oversight and SLAs.

Herramientas

Medidata Rave

Veeva Vault EDC

Oracle Clinical One

REDCap

Descripción del empleo

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

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

• 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+