Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Valuable Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include project specific training of CRAs, conducting assessment visits with CRAs, implementation of enrollment and recruitment strategies, preparation of the monitoring plan and other structural documentation and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.

Project Oversight

Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans,



ICH-GCP, local regulations and study timelines

Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above

May support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)

Oversee regional startup and feasibility activities

Assist in vendor management activities as required per project

Perform review of visit reports for quality, compliance and appropriate site management

Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan

Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress

Contribute to financia

📌 Clinical Operations Lead (India)
🏢 Alimentiv
📍 India