Principal IT Technologist - Clinical

Kornferry; Pune District; Hybrid; INR 1,200,000 - 1,800,000; Full time

Job summary

Kornferry is seeking a senior professional to lead configuration, validation, and deployment of EDC platforms including Medidata Rave, Veeva Vault EDC, Oracle Clinical One, and REDCap. You will collaborate with data management to design CRFs per protocol and CDASH/CDISC standards.

You will oversee IQ/OQ/PQ validation, support database lock, and ensure audit-ready data integrity while coordinating with clinical, regulatory, and IT teams to ensure global regulatory compliance.

Qualifications

• Experience configuring, validating, and deploying EDC platforms.
• Design CRFs aligned to protocol requirements and CDASH/CDISC standards.
• Lead IQ/OQ/PQ validation and maintain documentation.
• Support database lock activities and ensure audit-ready data integrity.
• Collaborate with clinical and regulatory teams for linguistic validation and endpoint alignment.
• Ensure compliance with global/regional regulatory requirements (21 CFR Part 11, GDPR, HIPAA, ISO 14155).
• Manage integration between EDC, ePRO, eConsent and other clinical systems.
• Develop and maintain SOPs and governance docs for platforms.
• Lead vendor management including contracts, SLAs, escalation.

Responsibilities

• Lead configuration, validation, and deployment of EDC platforms.
• Collaborate with data management to design CRFs aligned to CDISC standards.
• Oversee IQ/OQ/PQ validation and maintain all validation docs.
• Support database lock activities and ensure audit-ready data integrity.
• Coordinate with clinical and regulatory teams for linguistic validation and endpoint alignment.
• Ensure regulatory compliance across 21 CFR Part 11, GDPR, HIPAA, ISO 14155.
• Manage integration between EDC, ePRO, eConsent and other systems.
• Develop SOPs and governance documentation for platforms.

Skills

EDC platforms

CRF design

CDASH/CDISC

IQ/OQ/PQ

Regulatory compliance

Vendor management

Documentation

Cross-functional collaboration

eCOA

eConsent

Coding

Tools

Medidata Rave

Veeva Vault EDC

Oracle Clinical One

REDCap

Job description

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