Start-up Team Manager

Provável vaga fantasma

🕒 Junho 12

🌲 North Carolina – Remoto

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⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

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

• Lead site activation and manage complex site operations • Ensure compliance with regulatory standards • Support site recruitment and training efforts • Facilitate collaboration between trial sites and internal teams • Manage delivery of site activation within assigned regions • Oversee site activation according to timelines and quality standards • Coordinate SSU specialists across regions • Track critical-path site activation plans • Escalate regulatory and vendor setup issues • Facilitate knowledge transfer across countries within regions • Coordinate with Regional/Oversight Leads to resolve issues • Oversee EC submission strategy and required documents • Perform quality checks for central and local EC submission packages • Manage feasibility, site selection, contracts coordination, and EC/RA submissions • Ensure operational readiness, including site binders, ancillary supplies, lab kits, training, and system access • Monitor regional study status, identify risks, and provide metrics to the SSU Oversight Lead • Maintain regional startup metrics and tracking tools • Perform risk identification and contingency planning • Participate in risk escalation meetings and implement solutions • Manage country and site ICF timelines; review and approve country ICFs • Provide performance feedback to the People Manager and support staff learning opportunities • Prepare for and participate in country-level meetings • Oversee clinical trial insurance local policy country setup • Oversee and manage amendment implementation

🎯 Requisitos

• Bachelor's Degree • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • SSU experience in CRO or Pharma organizations highly preferred • Equivalency of appropriate education, training and/or directly related experience may be considered • Effective collaboration with cross-functional teams • Knowledge of cross-functional project management principles • Strong organizational and multitasking skills • Attention to detail • Ability to identify and mitigate risks related to contractual deliverables • Cross-cultural awareness and adaptability • Comprehensive understanding of clinical research and development, medical and therapeutic areas, phases, and terminology • Ability to lead, liaise, and coordinate cross-functional project teams • Knowledge of clinical development guidelines and directives • Ability to work in an upright and/or stationary position for 6-8 hours per day • Ability to perform repetitive hand movements • Frequent mobility required • Ability to lift and carry 15-20 lbs • Ability to use a variety of computer software • Ability to communicate and understand spoken information • Ability to perform under stress and multitask • Regular and consistent attendance

🏖️ Benefícios

• Global team environment • Collaboration and development opportunities • Commitment to scientific excellence

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