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

📌 Clinical It Technologist Pune
🏢 Kornferry
📍 Pune