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Clinical Trial Manager, FSP

đŸ”„ 1 minute ago

đŸ‡§đŸ‡· Brazil – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

đŸ§Ș Clinical Research

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 1 minute ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

đŸ„ 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 the Data Quality Plan and Master Action Plan ‱ Ensure timely setup, organization, content, and quality of relevant Trial Master File sections ‱ Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents ‱ Collaborate with project managers to prepare and present at client, bid defense, and hand-off meetings ‱ Collaborate with clinical and cross-functional teams, lead team meetings, and maintain timelines, resources, interactions, and quality ‱ Implement and train teams on standardized clinical monitoring processes ‱ Archive study documents and materials in a timely manner ‱ Prepare and monitor clinical activity timelines and metrics, provide status updates, review projects, 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 study-related issues ‱ Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions ‱ Ensure essential document quality meets Regulatory Compliance Review expectations and follow up on ethics committee questions ‱ Provide input into clinical activity forecasts ‱ Manage clinical resources, assign and 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 ‱ Equivalent combination of appropriate education, training, and/or directly related experience may be considered ‱ English language proficiency ‱ Familiarity with clinical monitoring practices, processes, and requirements ‱ Understanding of relevant regulations, including ICH/GCP and FDA guidelines ‱ Good computer skills, including Outlook, Excel, Word, and automated systems ‱ Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, and decision-making skills ‱ Ability to work effectively in a changing environment with complex or ambiguous situations ‱ Ability to evaluate workload against project budget and adjust resources accordingly ‱ Knowledge of budgeting, forecasting, and fiscal management ‱ Strong attention to detail ‱ Willingness and ability to frequently drive to site locations and travel domestically and internationally

đŸ–ïž Benefits

‱ Fully remote work mode ‱ Standard Monday–Friday work schedule ‱ Collaboration and professional development opportunities ‱ Mentoring and training environment ‱ Global team environment ‱ Exposure to scientific innovation and excellence

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