Global Senior Project Manager - FSP

🕒 Junho 19

🇨🇴 Colômbia – Remoto

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 65%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

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

• Own day-to-day management of global clinical studies • Lead cross-functional study teams across clinical operations, data management, biostatistics, medical monitoring, regulatory, supply chain, safety, and related functions • Align global strategy with regional execution • Drive study timelines, milestones, and deliverables • Develop and maintain study timelines, operational plans, risk management plans, and enrollment strategies • Oversee country start-up, site activation, recruitment, monitoring, and closeout • Ensure consistent global protocol execution • Manage external vendors and CRO partners • Track vendor performance metrics and service quality; resolve operational issues and escalations • Monitor study budgets and forecasts, spend, resource gaps, risks, and change management • Lead risk mitigation and contingency planning for recruitment delays, protocol deviations, data quality issues, supply shortages, and inspection readiness • Ensure compliance with ICH-GCP, local regulations, SOPs, and protocol requirements • Support inspection readiness and audits; oversee CAPAs when needed • Serve as the central operational contact for the study • Communicate updates to senior leadership, study teams, regional teams, sponsors, and partners • Lead governance meetings and study reviews • Monitor enrollment, data cleaning, query resolution, and database-lock readiness • Review KPIs and operational metrics and ensure timely delivery of quality data • Make operational decisions affecting study delivery and balance quality, speed, cost, and patient safety • Recommend process improvements and efficiencies

🎯 Requisitos

• Bachelor’s degree in life sciences or related discipline • At least 6+ years of relevant global study management experience • In-depth clinical research experience in study management, monitoring, and data management • Previous in-depth oncology experience • End-to-end global clinical study management experience across NA, EMEA, APAC, LATAM; China, Japan, and Africa experience is an asset • Proven experience from study feasibility through Clinical Study Report (CSR) • Experience with Phase II and Phase III studies; Phase I and Phase IV experience is an asset • Proven cross-functional leadership experience • Ability to contribute to clinical protocols, ICFs, study plans, clinical study risk management, and clinical systems • Strong clinical budget management experience • Strong vendor management experience, including CROs • Experience with competent authority inspections, including FDA, EMA, MHRA, and PMDA; drug-registration pivotal study experience is an asset • Fluent English, with ability to negotiate, discuss complex clinical topics, adapt messages, and present clear status updates to upper management • Excellent stakeholder management and oral and written communication skills • Outstanding interpersonal skills and demonstrated leadership skills • Strong understanding of clinical studies, drug development, sample management, associated processes, quality requirements, ICH/GCP guidelines, and SOPs • Good project management skills, including scope, budget, timeline, resource planning and management, and associated tools

🏖️ Benefícios

• Fully remote work arrangement • Standard Monday–Friday work schedule