Required skills:

- 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/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 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

📌 Principal IT Technologist - Clinical (Pune)
🏢 Kornferry
📍 Pune