Senior Non-Interventional Studies Clinical Team 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, complex program management, or project coordination responsibilities as required
• Develop clinical tools, Monitoring Plans, Monitoring Guidelines, Data Quality Plans, and contribute to Master Action Plans
• Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials
• Participate in developing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents
• Collaborate with project managers to prepare and present client, bid defense, and hand-off meetings
• Lead clinical team meetings and coordinate with other departments to maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Monitor clinical timelines, metrics, project status, recovery actions, monitoring visit reports, CRF collection, query resolution, and contractual obligations
• Communicate with study sites regarding protocol, patient participation, CRF completion, and other study-related issues
• Coordinate study start-up activities, regulatory submissions, essential document quality, and ethics committee questions as applicable
• Provide input into clinical activity forecasts
• Manage clinical resources, delegate responsibilities, and identify additional resource requirements
• Potentially conduct Accompanied Field Visits and manage project financials
• In assigned North American GPHS projects, potentially perform limited line management responsibilities

• 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
• Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
• Strong leadership, mentoring, training, motivation, and team integration skills
• Strong planning and organizational skills
• Strong interpersonal and problem-solving skills in a multicultural matrix organization
• 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
• Ability to evaluate workload against project budget and adjust resources
• 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, Word, and computerized applications
• Ability to independently manage clinical-only studies
• Frequent domestic and international travel
• Ability to drive to site locations

• Global team environment
• Collaboration and development opportunities
• Exposure to passion, innovation, and scientific excellence
• Frequent domestic and international travel opportunities