Medical Project Coordinator

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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

• Coordinate and review safety data using line listings, company dashboards, and visualization tools • Review data for safety trends, coding consistencies, and potential investigator-site follow-up • Identify potential issues and resolve or escalate them appropriately • Review safety data and provide summations for safety review meetings • Review designated sections of aggregate reports • Help create and review safety and medical management plans for studies • Ensure plan processes reflect contracted services • Help manage routine project implementation, forecasting, and coordination, including metrics and budget considerations • Monitor data-review status and escalate delays or risks to stakeholders and study leads • Present at business development, client, and investigator meetings • Participate in strategy and business development calls • Resolve complex problems through in-depth evaluation and offer solutions • Serve as primary contact for clinical/data management project teams • Assist management with training and mentoring

🎯 Requisitos

• Bachelor’s degree in nursing or related Health Sciences (Physician's Assistant) or licensed RN • 2+ years of relevant experience • 2+ years of clinical safety experience in clinical research monitoring, pharmacovigilance, or a combination of both • Equivalency through appropriate education, training, and/or directly related experience may be considered • Knowledge of GCPs for medical oversight of clinical trials and SAE processing • Knowledge of drug development and safety reporting • Knowledge of safety data trending, including coding • Working knowledge of biostatistics, data management, and clinical procedures • Strong problem-solving and critical-thinking skills • Good oral and written communication skills • Good attention to detail • Ability to work in a collaborative team environment • Ability to maintain a positive and professional demeanor in challenging circumstances • Ability to work in an upright and/or stationary position for 6–8 hours per day • Ability to perform repetitive hand movements and frequent mobility • Ability to lift and carry 15–20 lbs • Ability to access and use in-house and off-the-shelf computer software • Ability to communicate and understand spoken and written information • Ability to perform under stress and multitask • Regular and consistent attendance

🏖️ Benefícios

• Collaboration and development as part of the everyday experience • Reasonable accommodation for individuals with disabilities during application, interview, and essential job functions • Equal employment opportunity