Senior Clinical Trial Manager, FSP

🔥 1 minute ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Manage all clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP • Assume regional Lead CTM, Clinical Study Manager, process improvement, complex program management or project coordination responsibilities as required • Develop clinical tools such as Monitoring Plans and Monitoring Guidelines with the Data Quality Plan • Contribute to the Master Action Plan and ensure timely setup, organization, content and quality of Trial Master File sections • Participate in designing CRFs, CRF guidelines, patient informed consent templates and other protocol-specific documents • Collaborate with the project manager to prepare, organize and present at client meetings, including bid defense and hand-off meetings • Lead clinical team meetings and maintain timelines, resources, interactions and quality • Implement and train standardized clinical monitoring processes • Monitor clinical activity timelines and metrics, provide status updates, review projects and implement recovery actions • Review monitoring visit reports, manage CRF collection and query resolution, and monitor trial performance against contractual obligations • Conduct Accompanied Field Visits and manage project financials as required • Communicate with study sites about protocol, patient participation, case report forms and study-related issues • Coordinate study start-up activities and ensure essential document quality and timely regulatory submissions • Review and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, delegate responsibilities and identify additional resource requirements • Potentially perform limited line management responsibilities on assigned GPHS projects in North America

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 8+ 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 • Strong leadership, mentoring, training, team motivation and integration skills • Strong planning, organizational, prioritization, interpersonal and problem-solving skills • Solid understanding of change management principles • Comprehensive understanding of clinical monitoring practices, processes and requirements • Strong judgment, decision-making, escalation and risk management skills • Effective oral and written communication skills, including English language proficiency • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel and Word • Ability to independently manage clinical-only studies • Ability to work in a multicultural matrix organization • Ability to frequently travel domestically and internationally • Office environment exposure to electrical office equipment

🏖️ Benefits

• Fully remote work mode • Collaboration and development opportunities • Global team environment • Frequent domestic and international travel

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