Senior Non-Interventional Studies Clinical Team Manager

🔥 2 hours ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 12%

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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 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, Monitoring Plans, Monitoring Guidelines, Data Quality Plans, and contribute to Master Action Plans • Ensure timely setup, organization, content, quality, and archiving of Trial Master File documents and study materials • Participate in developing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents • Collaborate with project managers to prepare and present client, bid defense, and hand-off meetings • Lead clinical team meetings and coordinate with other departments to maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Monitor clinical timelines, metrics, project status, recovery actions, monitoring visit reports, CRF collection, query resolution, and contractual obligations • Communicate with study sites regarding protocol, patient participation, CRF completion, and other study-related issues • Coordinate study start-up activities, regulatory submissions, essential document quality, and ethics committee questions as applicable • Provide input into clinical activity forecasts • Manage clinical resources, delegate responsibilities, and identify additional resource requirements • Potentially conduct Accompanied Field Visits and manage project financials • In assigned North American GPHS projects, potentially perform limited line management responsibilities

🎯 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 • Combination of appropriate education, training and/or directly related experience may be considered as an equivalency • Strong leadership, mentoring, training, motivation, and team integration skills • Strong planning and organizational skills • Strong interpersonal and problem-solving skills in a multicultural matrix organization • 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 • Ability to evaluate workload against project budget and adjust resources • 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, Word, and computerized applications • Ability to independently manage clinical-only studies • Frequent domestic and international travel • Ability to drive to site locations

🏖️ Benefits

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

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