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