Senior 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, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan
• Contribute to the Master Action Plan for clinical-related documents
• Set up, organize, maintain, and ensure quality of relevant Trial Master File sections
• Participate in designing and developing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents
• Collaborate with project managers to prepare, organize, 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 and management tools, and implement recovery actions
• Review monitoring visit reports and 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 applicable
• Communicate with study sites regarding protocol, patient participation, CRF completion, and related issues
• Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions
• Ensure essential document quality meets Regulatory Compliance Review expectations
• Review and follow up on ethics committee questions
• Provide input into clinical activity forecasts
• Manage clinical resources, delegate clinical responsibilities, and identify additional resource needs
• Achieve final clinical deliverables within contracted time, quality, and cost expectations while maintaining profitability

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• 5+ years of previous relevant experience (comparable to 5+ years)
• Appropriate education, training and/or directly related experience may be considered as an equivalency
• 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 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 computerized applications
• Ability to travel frequently, domestically and internationally
• Ability to frequently drive to site locations

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