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 creative solutions and Technologies that reduce the burden of living with diabetes.
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/PQand 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
📌 Prin IT Technologist (Pune)
🏢 MiniMed
📍 Pune