Clinical IT Technologist

Technical specifications :

• Lead configuration, validation, and deployment of CTMS, eTMF, and Clinical Payment platforms (e.g., Veeva Vault CTMS, Medidata CTMS, Other CTMS platforms)
• Oversee system validation activities including IQ/OQ/PQ and maintain associated documentation in compliance with Computer System Validation (CSV) requirements
• Configure study-specific templates, visit schedules, and monitoring workflows aligned to protocol requirements
• Configure document taxonomies, metadata schemas, naming conventions, and filing plans
• Partner with Clinical Operations teams to manage site activation tracking, enrollment metrics, and investigator management within the CTMS
• Configure and support Risk-Based Monitoring (RBM) frameworks and central monitoring dashboards within the CTMS, eTMF, and Payment
• Collaborate with clinical monitors and data managers to ensure monitoring visit reports, action items, and deviations are captured and tracked appropriately
• Maintain audit trails and version control across all TMF documents for full inspection traceability
• Manage end-to-end integration across CTMS, eTMF, Clinical Payment platforms, EDC, IRT/IXRS, safety systems, and ERP/Financial systems (e.g., SAP, Oracle Financials) to ensure seamless clinical data and financial flow
• Develop and maintain SOPs, work instructions, and governance documentation across all three platform domains
• Lead vendor management activities including contract oversight, SLA monitoring, and escalation management for all clinical system vendors
• Ensure all systems comply with 21 CFR Part 11, GDPR, HIPAA, ICH E6 R2/R3 GCP, and ISO 14155 for medical device clinical investigations
• Partner with Clinical Operations, Data Management, Regulatory Affairs, Quality Assurance, Finance, Legal, Procurement, and IT teams
• Act as the primary point of contact for CROs, investigative sites, and clinical system technology vendors across all three platform domains