IT Technologist

IND-Medtronic MiniMed India Private Limited; Pune District; On-site; INR 800,000 - 1,400,000; Full time

Job summary

IND-Medtronic MiniMed India Private Limited in Pune is expanding its Global Diabetes Capability Center to transform diabetes management through advanced CTMS/eTMF platforms. You will collaborate with Clinical Operations, Regulatory Affairs, and QA to ensure compliant system validation and seamless data flow across ERP and financial modules.

The role focuses on configuring, validating, and maintaining CTMS/eTMF, RBM frameworks, and cross-functional documentation in a fast-paced, globally

Qualifications

• Experience with CTMS/eTMF validation and documentation.

Responsibilities

• Lead configuration, validation, and deployment of CTMS and eTMF platforms.

Skills

CTMS

eTMF

Clinical Payment platforms

IQ/OQ/PQ

CSV compliance

Audit trails

SOPs

Vendor management

Regulatory compliance

ERPs (SAP/Oracle)

Tools

Veeva Vault CTMS

Medidata CTMS

SAP

Oracle Financials

Job description

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.

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 CTMS, eTMF, and Clinical Payment platforms (e.g., Veeva Vault CTMS, Medidata CTMS, Other CTMS platforms)
• Oversee system validation activities including IQ/OQ/PQ and maintain associated documentation in compliance with Computer System Validation (CSV) requirements
• Configure study-specific templates, visit schedules, and monitoring workflows aligned to protocol requirements
• Configure document taxonomies, metadata schemas, naming conventions, and filing plans
• Partner with Clinical Operations teams to manage site activation tracking, enrollment metrics, and investigator management within the CTMS
• Configure and support Risk-Based Monitoring (RBM) frameworks and central monitoring dashboards within the CTMS, eTMF, and Payment
• Collaborate with clinical monitors and data managers to ensure monitoring visit reports, action items, and deviations are captured and tracked appropriately
• Maintain audit trails and version control across all TMF documents for full inspection traceability
• Manage end-to-end integration across CTMS, eTMF, Clinical Payment platforms, EDC, IRT/IXRS, safety systems, and ERP/Financial systems (e.g., SAP, Oracle Financials) to ensure seamless clinical data and financial flow
• Develop and maintain SOPs, work instructions, and governance documentation across all three platform domains
• Lead vendor management activities including contract oversight, SLA monitoring, and escalation management for all clinical system vendors
• Ensure all systems comply with 21 CFR Part 11, GDPR, HIPAA, ICH E6 R2/R3 GCP, and ISO 14155 for medical device clinical investigations
• Partner with Clinical Operations, Data Management, Regulatory Affairs, Quality Assurance, Finance, Legal, Procurement, and