Manager

• Lead clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP
• Manage clinical aspects of trials from launch through closeout
• Coordinate Clinical Management members allocated to projects on a regional or country basis
• Partner with Project Managers to establish training, tracking, and quality systems
• Own clinical deliverables within agreed timelines, budgets, and customer expectations
• Develop monitoring plans, monitoring guidelines, data quality plans, and related clinical tools
• Contribute to Master Action Plans and maintain relevant Trial Master File sections
• Participate in developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Prepare, organize, and present at client, bid defense, and hand-off meetings
• Lead clinical team meetings and collaborate cross-functionally to maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Monitor clinical activity timelines, metrics, monitoring visit reports, CRF collection, query resolution, and recovery actions
• Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
• Coordinate study start-up activities, regulatory submissions, and ethics committee follow-up when applicable
• Provide clinical resource forecasts, assign and delegate responsibilities, and identify additional resource needs
• Mentor and train junior staff
• May assume regional Lead CTM, Clinical Study Manager, program leadership, process improvement, or project coordination responsibilities
• May conduct Accompanied Field Visits and manage project financials

Explore Senior Clinical Team Manager – HemOnc at Thermo Fisher Scientific. Review requirements and application details.

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