Clinical Laboratory Study Manager – FSP

🕒 Outubro 21

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.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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Parexel

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1983

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Venture Round em 1990-01

Consulting • Healthcare • Logistics

Parexel é uma das maiores organizações de pesquisa clínica (CROs) do mundo, oferecendo serviços abrangentes para o processo de desenvolvimento clínico das Fases I a IV. A empresa é especializada em gestão de portfólio, gestão de ensaios clínicos, estratégia regulatória, acesso ao mercado e gestão do ciclo de vida para biofarmacêuticos. A Parexel busca acelerar a chegada de medicamentos que transformam vidas ao mercado, alavancando sua expertise clínica, regulatória e terapêutica. Com uma equipe global de mais de 21. 000 profissionais, a Parexel trabalha para integrar insights de pacientes e desenhos de estudo inovadores a fim de desenvolver tratamentos em áreas terapêuticas como oncologia, neurociência, doenças raras, entre outras. Seu foco está na condução de ensaios clínicos eficientes e centrados no paciente.

Descrição

• Work closely with Precision Medicine Leadership and cross-functional study teams to ensure quality samples and data are managed to support biomarker and non-biomarker evaluation • Provide project management oversight for sample tracking, usage, collection, destruction and data processing in alignment with protocols and regulatory requirements • Participate in cross-functional study team meetings and workstreams supporting precision medicine strategy • Serve as subject-matter expert on sample management and testing, anticipating challenges, managing project risks and responding to stakeholder queries • Develop and review sample-related sections of clinical protocols, Informed Consent Forms and sample management guidelines • Support specialty laboratory database creation and validation for data collection and sample kit tracking • Manage biosample process planning and execution, including storage, shipping and data transfer • Oversee acquisition and testing of clinical trial samples for biomarker research and liaise with vendors and stakeholders • Forecast operational costs and timelines; manage budgeting, invoicing and reporting • Coordinate with data management and biostatistics leads on biomarker data capture, blinding, transfer and reporting • Develop and review data transfer specifications and related documents • Train clinical teams and investigative sites on biospecimen collection, storage and shipment compliance • Ensure human sample transfers are documented, tracked, used and destroyed according to SOPs and regulations • Potentially lead clinical trial supplies and logistics, including sample and kit inventories, logistics, vendor management, documentation and LIMS tracking • Support precision medicine logistics strategies and evaluate emerging technologies and vendors • Potentially lead programming for clinical supplies and laboratory operations, developing tools and dashboards • Use technical tools, systems and programming languages to aggregate, extract, process and assess data • Assess laboratory databases, resolve biomarker data queries and support database lock activities • Complete required training, timesheets, expense reports and CV updates • Maintain effective relationships across platform lines, business/research units and enabling lines

🎯 Requisitos

• Candidates must be based in Argentina • Minimum of 6 years clinical research experience with academic, Contract Research Organization, pharmaceutical or biotech industry • Working knowledge of clinical drug development process and clinical databases • Knowledge of ICH, GCP guidelines, and US FDA and/or local country regulations as applicable • Bachelor degree in life sciences or equivalent (i.e., science, technology, engineering, or mathematics) or relevant work experience • Biology or equivalent major preferred • Strong project management and organization skills in a matrix environment • Analytical and problem-solving experience • Excellent written and verbal communication skills • Effective communication and interpersonal skills, with proven ability to build relationships internally and externally • Fluent in speaking/writing English • Proficiency in Microsoft Office applications, including strong Excel knowledge, as well as relevant role specific systems • Proficiency in Python, R, Perl, SQL or other programming languages, familiarity with APIs and Linux/Unix environments, if acting as programming lead for supplies and laboratory operations

🏖️ Benefícios

• No explicit benefits or compensation extras stated • Full-time employment • Travel not expected but may occur periodically

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