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 Plans and Master Action Plans
• Ensure timely setup, organization, content, and quality of relevant Trial Master File sections
• Participate in 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 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 required
• Communicate with study sites regarding protocol, patient participation, case report forms, and other study issues
• Coordinate study start-up activities and timely ethics committee and regulatory submissions
• 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 previous experience providing the knowledge, skills, and abilities to perform the job
• Equivalency may be considered through a combination of appropriate education, training, and/or directly related experience
• English language proficiency
• Familiarity with clinical monitoring practices, processes, and requirements
• Understanding of relevant regulations, including ICH/GCP and FDA guidelines
• Computer skills using Outlook, Excel, Word, and similar applications
• Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, communication, financial management, and attention-to-detail skills
• Ability to work effectively in a changing environment with complex or ambiguous situations
• Ability to evaluate workload against project budgets and adjust resources accordingly

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