
10,000+ employees
đ§Ź Biotechnology
đ Pharmaceuticals
đ„ Healthcare
Biotechnology âą Pharmaceuticals âą 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 lifeâsciences 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 massâspectrometry 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.
đ„ 27 minutes ago
Where this job comes from
Posted on Thermo Fisher Scientific's careers page, not through a job board
First seen by Remote Rocketship 27 minutes ago

10,000+ employees
đ§Ź Biotechnology
đ Pharmaceuticals
đ„ Healthcare
Biotechnology âą Pharmaceuticals âą 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 lifeâsciences 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 massâspectrometry 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.
âą Manage clinical operational and quality aspects of allocated moderate- to high-complexity studies in compliance with ICH GCP âą Assume regional Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned âą Develop clinical tools such as Monitoring Plans and Monitoring Guidelines with the Data Quality Plan âą Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections âą Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents âą Collaborate with project managers on client meetings, bid defense, and hand-off meetings âą Coordinate clinical teams and departments, lead team meetings, and maintain timelines, resources, interactions, and quality âą Implement and train standardized clinical monitoring processes âą Ensure timely archiving of documents and study materials âą Monitor clinical timelines, metrics, status, tracking tools, recovery actions, monitoring visit reports, CRF collection, and query resolution âą Continuously assess trial performance and contractual obligations âą Conduct Accompanied Field Visits and manage project financials as needed âą Communicate with study sites regarding protocols, patient participation, case report forms, and study issues âą Coordinate study start-up activities and regulatory submissions when appropriate âą Review and follow up on ethics committee questions âą Prepare clinical activity forecast estimates âą Manage clinical resources, delegate responsibilities, and identify additional resource needs âą May have limited line management responsibilities on assigned GPHS projects in North America
âą Bachelor's degree or equivalent and relevant formal academic / vocational qualification âą 8+ years of previous experience providing the knowledge, skills, and abilities to perform the job âą An equivalency combining appropriate education, training and/or directly related experience may be considered âą English language proficiency âą Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills âą Understanding of change management principles âą Comprehensive understanding of clinical monitoring practices, processes, and requirements âą Financial acumen and knowledge of budgeting, forecasting, and fiscal management âą In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines âą Strong computer skills, including Outlook, Excel, Word, and computerized applications âą Ability to independently manage clinical-only studies âą Willingness and ability to frequently drive to site locations and travel domestically and internationally
âą Global team environment âą Collaboration and development opportunities âą Passion, innovation, and commitment to scientific excellence
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