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