IT Technologist - Clinical Trial Technology Specialist (CTMS, eTMF)

USA-MiniMed Distribution Corp. 1018; Pune District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

MiniMed's Global Diabetes Capability Center in Pune is expanding to transform diabetes management through CTMS/eTMF and related platforms. This role focuses on configuring and validating CTMS systems, maintaining documentation, and collaborating with Clinical Operations, IT, and vendors to enable seamless data and financial workflows.

You will ensure compliance with 21 CFR Part 11, GDPR, HIPAA, and other regulatory standards while supporting end-to-end integration across platforms like EDC,

Qualifications

• Experience with CTMS configuration and study templates.
• Knowledge of CSV/21 CFR Part 11 and data integrity.
• Ability to work with CROs and cross-functional teams.

Responsibilities

• Lead configuration, validation, and deployment of CTMS, eTMF, and Clinical Payment platforms.
• Oversee system validation activities including IQ/OQ/PQ and documentation.
• Configure study-specific templates, visit schedules, and monitoring workflows.
• Configure document taxonomies, metadata schemas, naming conventions, and filing plans.
• Partner with Clinical Operations to manage site activation tracking, enrollment metrics, and investigator management.
• Configure and support RBM frameworks and dashboards within the CTMS, eTMF, and Payment.
• Collaborate with clinical monitors and data managers to ensure monitoring visit reports are tracked.
• Maintain audit trails and version control across all TMF documents.
• Manage end-to-end integration across CTMS, eTMF, Clinical Payment platforms, EDC, IRT/IXRS, safety systems, and ERP/Financial systems (SAP, Oracle).
• Develop and maintain SOPs, work instructions, and governance across all three platform domains.
• Lead vendor management including contract oversight, SLA monitoring, and escalation for vendors.
• Ensure systems comply with 21 CFR Part 11, GDPR, HIPAA, ICH E6 R2/R3 GCP, ISO 14155 for medical device investigations.
• Partner with Clinical Operations, Data Management, Regulatory Affairs, QA, Finance, Legal, Procurement, and IT teams.
• Act as the primary contact for CROs, sites, and clinical system technology vendors.

Skills

CTMS configuration

IQ/OQ/PQ validation

Regulatory compliance

Veeva Vault CTMS

Cross-functional collaboration

Tools

Veeva Vault CTMS

Medidata CTMS

SAP integration

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.

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 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 IT teams
• Act as the primary point of contact for CROs, investigative sites, and clinical system technology vendors across all three platform domains

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: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.
• Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced