Clinical Trial Manager
Core
Coordinates country cross-functional teams to ensure study enrollment targets, timelines, and inspection readiness for clinical trials.
Role type
Senior Clinical Trial Manager (Country Level)
Builds
Clinical trial operations and patient recruitment strategies for specific countries
Domain
Biopharmaceuticals / Clinical Research
Required skills
Cross-functional team coordination, patient recruitment strategy, risk mitigation, vendor management, regulatory compliance, CAPA management, site relationship management, data integrity management
Preferred skills
Pre-Study Evaluation Visits, Site Initiation Visits, Health Authority submission support
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 entered in Clinical Trial Management Systems is current and complete; Validate study-related materials and prepare country-specific documents; Review Site Monitoring visit reports and ensure appropriate documentation; Coordinate database locks and query follow-up; Ensure inspection readiness of assigned trials; Coordinate Corrective Actions/Preventive Actions (CAPA) for audit findings; Manage site relationships including CRO issues; Conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs); Support preparing submissions to local Health Authorities and Ethics Committees.
