Clinical Trial Manager, FSP

🔥 9 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 15%

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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 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

🎯 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

🏖️ Benefits

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

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