Senior Clinical Trial Manager, FSP

• Manage all clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP
• Assume regional Lead CTM, Clinical Study Manager, process improvement, complex program management or project coordination responsibilities as required
• Develop clinical tools such as Monitoring Plans and Monitoring Guidelines with the Data Quality Plan
• Contribute to the Master Action Plan and ensure timely setup, organization, content and quality of Trial Master File sections
• Participate in designing CRFs, CRF guidelines, patient informed consent templates and other protocol-specific documents
• Collaborate with the project manager to prepare, organize and present at client meetings, including bid defense and hand-off meetings
• Lead clinical team meetings and maintain timelines, resources, interactions and quality
• Implement and train standardized clinical monitoring processes
• Monitor clinical activity timelines and metrics, provide status updates, review projects and implement recovery actions
• Review monitoring visit reports, manage CRF collection and query resolution, and monitor trial performance against contractual obligations
• Conduct Accompanied Field Visits and manage project financials as required
• Communicate with study sites about protocol, patient participation, case report forms and study-related issues
• Coordinate study start-up activities and ensure essential document quality and timely regulatory submissions
• Review and follow up on ethics committee questions
• Provide input into clinical activity forecasts
• Manage clinical resources, delegate responsibilities and identify additional resource requirements
• Potentially perform limited line management responsibilities on assigned GPHS projects in North America

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Strong leadership, mentoring, training, team motivation and integration skills
• Strong planning, organizational, prioritization, interpersonal and problem-solving skills
• Solid understanding of change management principles
• Comprehensive understanding of clinical monitoring practices, processes and requirements
• Strong judgment, decision-making, escalation and risk management skills
• Effective oral and written communication skills, including English language proficiency
• Strong financial acumen and knowledge of budgeting, forecasting and fiscal management
• Strong attention to detail
• In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Strong computer skills, including Outlook, Excel and Word
• Ability to independently manage clinical-only studies
• Ability to work in a multicultural matrix organization
• Ability to frequently travel domestically and internationally
• Office environment exposure to electrical office equipment

• Fully remote work mode
• Collaboration and development opportunities
• Global team environment
• Frequent domestic and international travel