Senior Clinical Team Manager – Neurology

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🕒 Junho 10

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Accountable for achieving the final clinical deliverable (usually clean data from valuable patients as specified in the study protocol) within the time period specified in the contract with the customer • Interprets data on project issues and makes good business decisions with support from expert team members or line manager • Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP • Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan • Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents • Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central) • Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings • Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained • Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies • Responsible for the timely archiving of documents and study materials for the department

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides knowledge, skills, and abilities to perform the job (comparable to 8+ years) • PREFERRED therapeutic indication experience: Ophthalmology (General ophthalmology, Diabetic Macular Edema & Geographic Atrophy), Rare Disease (Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD - CAR-T experience a plus), Sleep, Epilepsy, and/or Psychiatry • PREFERRED experience level: 3+ years of CTM experience (North America) + global gCTM experience +/- biotech experience • Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams • Good planning and organizational skills to enable effective prioritization of workload • Solid interpersonal and problem-solving skills to enable working in a multicultural matrix organization • Capable of working effectively in a changing environment with sophisticated/ambiguous situations • Familiarity with the practices, processes, and requirements of clinical monitoring • Good judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Capable of evaluating workload against project budget and adjusting resources accordingly • Sound financial acumen and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Good digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

🏖️ Benefícios

• Competitive remuneration • Annual incentive plan bonus • Healthcare • Range of employee benefits