Principal IT Technologist - Clinical

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