Senior Clinical Lead/ Senior Clinical Trial Manager

đŸ”„ 27 minutes ago

đŸ‡§đŸ‡· Brazil – Remote

⏰ Full Time

🟠 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 27 minutes 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 moderate- to high-complexity studies in compliance with ICH GCP ‱ Assume regional Lead CTM, Clinical Study Manager, process improvement, program management, management, or project coordination responsibilities as assigned ‱ Develop clinical tools such as Monitoring Plans and Monitoring Guidelines with the Data Quality Plan ‱ Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections ‱ Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents ‱ Collaborate with project managers on client meetings, bid defense, and hand-off meetings ‱ Coordinate clinical teams and departments, lead team meetings, and maintain timelines, resources, interactions, and quality ‱ Implement and train standardized clinical monitoring processes ‱ Ensure timely archiving of documents and study materials ‱ Monitor clinical timelines, metrics, status, tracking tools, recovery actions, monitoring visit reports, CRF collection, and query resolution ‱ Continuously assess 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 issues ‱ Coordinate study start-up activities and regulatory submissions when appropriate ‱ Review and follow up on ethics committee questions ‱ Prepare clinical activity forecast estimates ‱ Manage clinical resources, delegate responsibilities, and identify additional resource needs ‱ May have limited line management responsibilities on assigned GPHS projects in North America

🎯 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 ‱ An equivalency combining appropriate education, training and/or directly related experience may be considered ‱ English language proficiency ‱ Strong leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills ‱ Understanding of change management principles ‱ Comprehensive understanding of clinical monitoring practices, processes, and requirements ‱ 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, including Outlook, Excel, Word, and computerized applications ‱ Ability to independently manage clinical-only studies ‱ Willingness and ability to frequently drive to site locations and travel domestically and internationally

đŸ–ïž Benefits

‱ Global team environment ‱ Collaboration and development opportunities ‱ Passion, innovation, and commitment to scientific excellence

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