Clinical Research Manager

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🕒 Junho 9

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TFS HealthScience - Contract Research Organization

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2007

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A TFS HealthScience é uma das principais Organizações de Pesquisa por Contrato (CRO) globais, que colabora com empresas de biotecnologia e farmacêuticas para impulsionar o desenvolvimento clínico. Oferece um amplo portfólio de soluções, incluindo desenvolvimento clínico de Fases I–III, estudos de evidências do mundo real (Fase IV) e soluções estratégicas de resourcing (alocação de profissionais). A TFS HealthScience é especializada em diversas áreas terapêuticas, como dermatologia, medicina interna, neurociências, oncologia e hematologia, oftalmologia, pediatria, doenças raras e medicamentos órfãos. Seu objetivo é levar tratamentos aos pacientes com mais rapidez, combinando capacidades full service e alcance global com a flexibilidade e a abordagem personalizada de uma CRO de médio porte.

Descrição

• Oversee day‑to‑day clinical operations to ensure delivery according to protocol, SOPs, ICH/GCP, and regulatory requirements • Serve as the primary operational contact for Sponsors, providing updates, managing expectations, and ensuring high‑quality study execution • Lead and support CRAs, including training, supervision, performance oversight, co‑monitoring, and review/approval of monitoring visit reports • Ensure site and country performance through proactive review of monitoring activities, protocol deviations, data listings, recruitment progress, and issue escalation • Maintain oversight of study documentation, including TMF quality, CTMS accuracy, monitoring plans, training plans, and study‑specific materials • Collaborate with the Project Manager on study planning, investigator payments, resource allocation, study communications, and revenue forecasting • Contribute to study meetings, Investigator Meetings, feasibility assessments, and, when required, local project management, CRA support, and bid defense activities

🎯 Requisitos

• Minimum 5 years of clinical monitoring experience in a CRO, pharmaceutical, or biotechnology environment • At least 1 year of experience as a Clinical Research Manager (CRM) • 1+ years of experience in Ophthalmology (OPH), ideally within retina indications such as DME, AMD, GA, RVO, or inherited retinal diseases (IRDs) • Fluency in English, Spanish and Portuguese is required • Strong understanding of ICH/GCP, regulatory requirements, and clinical operations processes • Demonstrated ability to lead CRAs, manage study deliverables, and collaborate effectively with cross-functional teams

🏖️ Benefícios

• Competitive compensation package • Comprehensive benefits • Personal and professional growth opportunities