Clinical Team Manager – Neuro

🔥 17 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

👔 Manager

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 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 Data Quality Plans and Master Action Plans • Establish, organize, maintain, and archive relevant local and central Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and other departments; lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes and corporate policies • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects with tracking tools, and implement recovery actions • Review monitoring visit reports, manage CRF collection and query resolution, and monitor or co-monitor clinical trials • 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 related issues • Coordinate study start-up activities and timely ethics committee and regulatory submissions • Ensure essential document quality and follow up on ethics committee questions • Provide input into clinical activity forecasts and manage clinical resources, assignments, delegations, and 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 • Experience in end-to-end study management of studies • Early Phase and Start-up experience preferred • Familiarity with clinical monitoring practices, processes, and requirements • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • English language proficiency • Computer skills using Outlook, Excel, Word, and similar computerized applications • Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, communication, financial management, budgeting, forecasting, fiscal management, and attention-to-detail 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 • Therapeutic-area experience in psychiatry, Parkinson's disease, sleep disorders, epilepsy, hearing loss, or listed rare diseases; CAR-T experience is a plus

🏖️ Benefits

• Global team environment • Collaboration and development opportunities • Exposure to passion, innovation, and scientific excellence • Standard Monday-Friday work schedule

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