Clinical Team Manager, Internal Medicine

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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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, management, or project coordination responsibilities as needed • Develop clinical tools such as Monitoring Plans and Monitoring Guidelines in conjunction 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 developing CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents • Collaborate with project managers to prepare, organize, and present at client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and other departments to meet project deliverables • 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 • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects using tracking and management tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor clinical trials, assess performance, and ensure contractual obligations are met • Conduct Accompanied Field Visits and manage project financials as needed • Communicate with study sites about protocols, patient participation, case report forms, and other study issues • Coordinate study start-up activities and ensure essential document quality meets Regulatory Compliance Review expectations • Ensure timely regulatory submissions 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 relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities • Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities • An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be considered sufficient • Strong leadership, mentoring, training, team motivation, planning, organizational, interpersonal, problem-solving, judgment, decision-making, escalation, risk management, communication, and attention-to-detail skills • Strong understanding of change management principles and clinical monitoring practices, processes, and requirements • Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management • In-depth understanding of relevant regulations such as ICH/GCP and FDA guidelines • Strong computer skills, including Outlook, Excel, Word, and computerized applications • Ability to independently manage clinical-only studies • English language proficiency

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Scientific excellence-focused work environment • Frequently drives to site locations and frequently travels both domestic and international

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