Clinical Trial Manager – FSP

• 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 and master action plans
• Set up, organize, maintain, and archive Trial Master File sections and study materials
• Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers to prepare and present at client, 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
• Prepare and monitor clinical timelines and metrics; provide status updates and implement recovery actions
• Review monitoring visit reports and manage CRF collection and query resolution
• Monitor or co-monitor clinical trials and conduct Accompanied Field Visits when required
• Communicate with study sites regarding protocols, patient participation, CRF completion, and related issues
• Coordinate study start-up activities and ethics committee and regulatory submissions
• Review ethics committee questions and ensure essential document quality
• Provide input to clinical activity forecasts and manage clinical resources, responsibilities, and additional resource needs
• Ensure final clinical deliverables meet contractual time, quality, and cost expectations while maintaining profitability

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of comparable experience
• Combination of appropriate education, training and/or directly related experience may be considered as an equivalency
• Leadership, mentoring, training, and team motivation skills
• Planning and organizational skills
• Interpersonal and problem-solving skills in a multicultural matrix organization
• Ability to work effectively in changing environments with complex or ambiguous situations
• Familiarity with clinical monitoring practices, processes, and requirements
• Judgment and decision-making skills
• Effective oral and written communication skills, including English language proficiency
• Ability to evaluate workload against project budget 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

• Fully remote work mode
• Global team environment
• Collaboration and development opportunities
• Scientific excellence-focused work environment