Clinical Trial Manager
Core
Coordinates country cross-functional teams to manage clinical trial execution, patient recruitment, and regulatory compliance for a specific country.
Role type
Senior Clinical Trial Manager (Country Lead)
Builds
Country-level clinical study operations and patient enrollment pipelines
Domain
Biopharmaceuticals / Clinical Research
Required skills
cross-functional team coordination, patient recruitment strategy, risk mitigation, vendor management, regulatory compliance, CAPA management, site relationship management, inspection readiness
Preferred skills
Pre-Study Evaluation Visits (PSEVs), Site Initiation Visits (SIVs), site closure activities, local Health Authority submissions
Technologies
Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), eTMF
Responsibilities
Coordinate country cross-functional teams and act as main point of contact for the Country; Develop country-level patient recruitment strategy and risk mitigation; Lead problem-solving and resolution efforts including risk management and escalation; Assess and set up vendors during study start-up; Ensure data completeness in CTMS and EDC; Validate study materials and prepare country-specific documents; Review Site Monitoring visit reports and ensure issue resolution; Coordinate database locks and query follow-up; Ensure inspection readiness and support Health Authority inspections; Manage Corrective and Preventive Actions (CAPA) for audit findings; Lead local study team meetings; Manage site relationships including CRO issues; Conduct PSEVs, SIVs, and site closure activities; Support submissions to local Health Authorities and Ethics Committees.