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

Overview

Lead configuration, validation and deployment of clinical research technology platforms (EDC, eCOA, eConsent) for MiniMed's Diabetes business, as a Specialist-level individual contributor within the Global Diabetes Capability Center in Pune.

What you'll do

• Lead configuration, validation and deployment of EDC platforms (e.g., Medidata Rave, Veeva Vault EDC, Oracle Clinical One, REDCap), eCOA, eConsent and 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 the 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.

What you'll need

• 7+ years of experience with a bachelor's degree, or 5+ years of experience with an advanced degree, or 12+ years of experience with a high school diploma or equivalent.
• Mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.

Details

• Location: Pune, Maharashtra, India.
• Employment type: Specialist career stream, individual contributor role.