Clinical Team Manager – Neuro

🕒 July 14

🌲 North Carolina – Remote

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⏰ Full Time

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

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👻 Ghost score 31%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 • Develop clinical tools and contribute to the Data Quality Plan, Master Action Plan, and Trial Master File • Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents • Collaborate with project managers and clinical teams to prepare and present client meetings • Lead team meetings and maintain project timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Ensure timely archiving of study documents and materials • Monitor clinical activity timelines and metrics, provide status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Continuously monitor or co-monitor clinical trials and ensure contractual obligations are met • Communicate with study sites regarding protocol, patient participation, CRF completion, and other study issues • Coordinate study start-up activities and 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, delegation, 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 healthcare, nursing, medicine, or related-discipline experience may be considered with clinical trial experience and significant clinical expertise • Experience in end-to-end study management • Early Phase and Start-up experience preferred • Therapeutic experience in Neurology and listed related therapeutic areas preferred; CAR-T experience a plus • Leadership, mentoring, training, team motivation, and integration skills • Planning, organization, prioritization, interpersonal, and problem-solving skills • Familiarity with clinical monitoring practices, processes, and requirements • Good 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 computerized applications • Ability to work in a changing environment with complex or ambiguous situations • Frequent domestic and international travel to site locations

🏖️ Benefits

• Collaboration and development opportunities • Reasonable accommodation for individuals with disabilities • Equal opportunity employment

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