Clinical Trial Manager

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP
• Assume Clinical Study Manager responsibilities on small or less complex projects when required
• Develop clinical tools, Monitoring Plans, Monitoring Guidelines, and contribute to Data Quality Plans and Master Action Plans
• Ensure timely setup, organization, content, and quality of relevant Trial Master File sections
• Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings
• Collaborate with clinical teams and other departments to meet project deliverables
• Lead team meetings and maintain timelines, resources, interactions, and quality
• Implement and train teams on standardized clinical monitoring processes
• Archive documents and study materials in a timely manner
• Prepare and monitor clinical activity timelines and metrics
• Provide project status updates, review projects using tracking tools, and implement recovery actions
• Review monitoring visit reports, manage CRF collection and query resolution
• Monitor or co-monitor clinical trials to assess performance and meet contractual obligations
• Conduct Accompanied Field Visits and manage project financials in smaller regions when required
• Communicate with study sites regarding protocol, patient participation, case report forms, and study issues
• Coordinate study start-up activities and ethics committee and regulatory submissions when appropriate
• Ensure essential document quality and follow up on ethics committee questions
• Provide input into clinical activity forecasts
• Manage clinical resources, delegate responsibilities, and identify additional resource requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of comparable experience
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered
• Leadership, mentoring, training, motivation, and team integration skills
• Planning and organizational skills
• Interpersonal and problem-solving skills in a multicultural matrix organization
• Ability to work effectively in changing environments with complex/ambiguous situations
• Familiarity with clinical monitoring practices, processes, and requirements
• Good judgment and decision-making skills
• Effective oral and written communication skills, including English language proficiency
• Ability to evaluate workload against project budgets and adjust resources
• Financial acumen and knowledge of budgeting, forecasting, and fiscal management
• Strong attention to detail
• Understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Computer skills using Outlook, Excel, Word, and similar applications
• Frequent domestic and international travel and driving to site locations

• Global team environment
• Collaboration and development opportunities
• Passion, innovation, and commitment to scientific excellence
• Standard Monday-Friday work schedule