Clinical Study Manager

🕒 6 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

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ICON plc

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1990

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A ICON plc é uma provedora global de serviços clínicos, de consultoria e comerciais que atendem a diversos setores das indústrias de saúde e farmacêutica. A empresa oferece uma ampla gama de soluções clínicas, incluindo ensaios clínicos descentralizados, soluções de segurança cardíaca, laboratórios clínicos de fases iniciais e imagem médica. A ICON também fornece soluções de tecnologia que apoiam o desenvolvimento de medicamentos desde as fases iniciais até o pós-comercialização. Sua expertise terapêutica abrange cardiovascular, oncologia, medicina interna e mais, com forte foco em terapias transformadoras, como terapias celulares e gênicas e biossimilares. Reconhecida como uma das principais CROs (Contract Research Organisations), a ICON oferece regularmente thought leadership e contribui para publicações e eventos do setor. Seus serviços são personalizados para otimizar ensaios clínicos, fornecer inteligência regulatória e gerar evidências do mundo real por meio de análise de dados robusta e soluções centradas no paciente.

Descrição

• Lead and coordinate project activities for an FSP clinical study management role dedicated to one pharmaceutical company • Support operational delivery in close collaboration with the Global Trial Study Leader • Execute select studies in compliance with ICH GCP, local regulations, SOPs, schedule, budget, and quality standards • Plan and operationally execute specific tasks within assigned clinical trials • Coordinate with functional leads to deliver milestones and meet project objectives • Oversee strategic partners, including CRO/vendor selection, budget and contract negotiation, and performance supervision • Review and approve key monitoring documents and plans, and review monitoring outputs, decisions, and actions • Conduct oversight monitoring visits, as applicable • Review and endorse relevant study plans • Manage and attend study team meetings and review agendas and minutes • Review protocol deviation outcomes and actions to identify trends across sites or studies • Monitor study-level issues, risks, and decisions and implement mitigation strategies • Review and own trial operational data, including CTMS data • Review and provide oversight of internal trial reports • Ensure studies remain inspection ready and support regulatory inspections • Prepare for agency inspections, including document readiness, tracking, storyboard development, and related preparations • Support data review for database lock and CSR writing and review, including appendices • Collect, review, and file study documents for the trial master file and regulatory filing

🎯 Requisitos

• 5+ years’ experience in the pharmaceutical industry and/or clinical research organization • 3+ years’ clinical study management oversight • Significant study management support experience, such as clinical trial assistant/associate or lead CRA • Experience in early phase clinical studies or Phase 2 and 3 studies • Experience with global/international studies or programs • Experience in more than one therapeutic area is advantageous • Proven track record of successfully managing projects within scope, time, and budget constraints • Experience in vendor selection and oversight • Strong leadership and organizational skills • Excellent communication and interpersonal skills • Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP • Awareness of local country requirements may be required • Proficiency in project management tools and methodologies • PMP or PRINCE2 certification is advantageous • Detail-oriented, proactive, and adaptable • Fluent business English, oral and written • Legal right to work in the country where the role is based

🏖️ Benefícios

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Stability, career development and a collaborative environment • Minimal travel; occasional travel opportunity to support a key trial meeting may arise