Clinical Trial Manager

🔥 7 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – 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, including 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, patient informed consent templates, and other 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 communicate regularly to maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Archive documents and study materials in a timely manner • Achieve final clinical deliverables within contractual timelines by monitoring activity timelines and metrics, providing status updates, reviewing tracking tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution • Continuously monitor or co-monitor clinical trials and assess performance against contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites regarding protocols, patient participation, case report forms, and other 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 • Review and follow up on ethics committee questions • Provide input into clinical activity forecasts • Manage clinical resources, delegate clinical 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 • Leadership, mentoring, training, motivation, and team integration skills • Planning and organizational skills • Interpersonal and problem-solving skills in a multicultural matrix organization • Ability to work effectively in changing environments with complex or ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budget and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and similar applications • Frequent domestic and international travel and driving to site locations

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused workplace

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