Senior Clinical Trial Manager, FSP

🔥 1 minute ago

🇲🇽 Mexico – 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 clinical operational and quality aspects of moderate- to high-complexity studies in compliance with ICH GCP • Assume regional Lead Clinical Trial Manager, Clinical Study Manager, process improvement, program management, or project coordination responsibilities as assigned • Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan • Contribute to the Master Action Plan and ensure timely organization, content, and quality of Trial Master File sections • Participate in the design and development of 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 coordinate timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Ensure timely archiving of study documents and materials • Monitor clinical activity timelines and metrics, provide project status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor trial performance and contractual obligations • Conduct Accompanied Field Visits and manage project financials as needed • Communicate with study sites regarding protocols, patient participation, case report forms, and study-related issues • Coordinate study start-up activities and regulatory submissions when appropriate • Review and follow up on ethics committee questions • Prepare forecast estimates for clinical activities • Manage clinical resources, delegate responsibilities, and identify additional resource requirements • Provide limited line management for assigned Government & Public Health Studies projects in North America

🎯 Requirements

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification • 8+ years of previous experience providing relevant knowledge, skills, and abilities • An equivalency combining appropriate education, training, and/or directly related experience may be considered • Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, and risk-management skills • Strong understanding of change management principles • Comprehensive understanding of clinical monitoring practices, processes, and requirements • Effective oral and written communication skills, including English language proficiency • Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management • In-depth understanding of relevant regulations, including ICH/GCP and FDA guidelines • Strong computer skills and proficiency with Outlook, Excel, Word, and computerized applications • Ability to independently manage clinical-only studies • Frequent travel to domestic and international site locations

🏖️ Benefits

• Fully remote work arrangement • Standard Monday-Friday work schedule • Collaboration and professional development opportunities • Mentoring and training opportunities • Global team environment • Domestic and international travel opportunities

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