Clinical Trial Manager – FSP
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Job Description
Clinical Trial Manager managing clinical operations, quality, timelines, and compliance for Thermo Fisher Scientific studies in Brazil. Coordinating teams, sites, regulatory submissions, and trial deliverables.
Responsibilities:
- 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, 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 designing 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
- Lead clinical team meetings and maintain timelines, resources, interactions, and quality
- Implement and train teams on standardized clinical monitoring processes
- Prepare and monitor clinical activity timelines and metrics, provide project status updates, review tracking tools, and implement recovery actions
- Review monitoring visit reports, manage CRF collection and query resolution, and monitor or co-monitor clinical trials
- 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 ethics committee and regulatory submissions when appropriate
- Ensure essential document quality and follow up on ethics committee questions
- Provide input into clinical activity forecasts and manage clinical resources, assignments, delegation, and additional resource requirements
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 through a combination of appropriate education, training and/or directly related experience may be considered
- Knowledge of clinical monitoring practices, processes, and requirements
- Understanding of relevant regulations, including ICH/GCP and FDA guidelines
- English language proficiency
- Good computer skills, including Outlook, Excel, and Word
- Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, communication, financial management, budgeting, forecasting, and attention-to-detail skills
- Ability to work effectively in a changing environment with complex/ambiguous situations and multicultural matrix organizations
- Ability to evaluate workload against project budget and adjust resources accordingly
- Frequent domestic and international travel and driving to site locations
Benefits:
- Global team environment
- Collaboration and development opportunities
- Exposure to passion, innovation, and scientific excellence
- Full-time employment
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