Senior Clinical Lead/ Senior Clinical Trial Manager

• Manage 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, program management, management, or project coordination responsibilities as assigned
• 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, informed consent templates, and other protocol-specific documents
• Collaborate with project managers on client meetings, bid defense, and hand-off meetings
• Coordinate clinical teams and departments, lead team meetings, and maintain timelines, resources, interactions, and quality
• Implement and train standardized clinical monitoring processes
• Ensure timely archiving of documents and study materials
• Monitor clinical timelines, metrics, status, tracking tools, recovery actions, monitoring visit reports, CRF collection, and query resolution
• Continuously assess trial performance and contractual obligations
• Conduct Accompanied Field Visits and manage project financials as needed
• Communicate with study sites regarding protocols, patient participation, case report forms, and study issues
• Coordinate study start-up activities and regulatory submissions when appropriate
• Review and follow up on ethics committee questions
• Prepare clinical activity forecast estimates
• Manage clinical resources, delegate responsibilities, and identify additional resource needs
• May have 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
• An equivalency combining appropriate education, training and/or directly related experience may be considered
• English language proficiency
• Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills
• Understanding of change management principles
• Comprehensive understanding of clinical monitoring practices, processes, and requirements
• Financial acumen and knowledge of budgeting, forecasting, and fiscal management
• In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Strong computer skills, including Outlook, Excel, Word, and computerized applications
• Ability to independently manage clinical-only studies
• Willingness and ability to frequently drive to site locations and travel domestically and internationally

• Global team environment
• Collaboration and development opportunities
• Passion, innovation, and commitment to scientific excellence