Biospecimen Project Manager

🕒 5 dias atrás

🍂 Massachusetts, Tennessee – Remoto

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⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 10%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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LabConnect

501 - 1000 funcionários

Fundada em 2002

🏥 Saúde

💊 Farmacêutico

🧬 Biotecnologia

💰 $24.500.000 Series A - LabConnect em 2017-06

Healthcare • Pharmaceuticals • Biotechnology

A LabConnect é uma parceira global de soluções laboratoriais centrais que fornece serviços laboratoriais e de dados orientados por tecnologia, personalizados, orquestrados e escaláveis para apoiar ensaios clínicos e o desenvolvimento de medicamentos em todo o mundo. Suas ofertas incluem testes bioanalíticos centrais e especializados, suporte radiofarmacêutico, coleta descentralizada/perto de casa, kits de coleta personalizados e kits em alto volume, diagnósticos complementares e validação de ensaios, gerenciamento e harmonização de dados, gerenciamento de projetos regulatórios e científicos e suporte comercial/pós-mercado. A LabConnect atende patrocinadores e CROs em várias áreas terapêuticas (oncologia, vacinas, terapia celular e gênica/MTAPs e mais), enfatizando a supervisão de programas e a execução operacional para pesquisa clínica.

Descrição

• Serve as the centralized point of contact for biospecimen lifecycle management and resulting analytical data from clinical studies • Drive biospecimen lifecycle management from sample receipt to analysis and final disposition • Ensure accurate specimen metadata • Communicate study specimen updates to client groups and stakeholders • Improve specimen management efficiency by sharing knowledge and best practices • Provide site support and drive query resolution • Participate in or lead special projects • Adhere to client policies and Standard Operating Procedures • Review clinical study protocols and service providers’ scope of work documents for sample handling and processing details • Set up and maintain complex study sample trackers • Create and manage project plans • Manage data transfer plans with analytical laboratories • Manage data received from external and internal laboratories, including exploratory studies • Manage specimen metadata discrepancies and ensure resolution • Submit specimens for analytical assays according to study timelines • Review specimen receipt status and data completeness • Support database locks by ensuring all specimens have final results and data transfer is complete • Create reports for data management as needed • Support annual and long-term planning projections • Provide support and act as a technical resource within the department

🎯 Requisitos

• B.A./B.S. in life sciences, medical technology, or related field, required • 3–5 years experience managing biospecimen samples from receipt to analysis and final disposition, required • Understanding of transaction-based inventory and data management systems as well as clinical trial processes • Understanding of ICH, GCP, GLP, and local regulations • Project Management experience strongly desired • Excellent communication skills • Strong planning, organizational, and time management skills • Very high attention to detail and excellent multi-tasking skills • Proficient in all Microsoft products, including Excel, with macro and template building knowledge • Experience with LIMS systems

🏖️ Benefícios

• 100% remote work arrangement • Ability to work standard east coast business hours • Potential maximum travel 2–4 times per year in Cambridge, MA

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