Clinical Trial Manager II

🕒 Setembro 21

🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

O que significa: quão provável esta vaga está aberta sem contratação ativa.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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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• Provide site management oversight, clinical monitoring, and central monitoring deliverables focused on patient safety, protocol/GCP/regulatory compliance, and data integrity • Oversee site interactions from activation through closeout, including recruitment and investigator payments • Identify clinical trial risks and develop risk mitigations • Review study scope, budget, protocol content, and contractual obligations • Monitor operational data, metrics, reports, timelines, quality, and budget risks • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site communications and interact with principal investigators and site staff • Coordinate handoffs with Study Start Up, Patient Recruitment, and Data Management teams • Develop and maintain clinical study tools and templates, including Clinical Monitoring Plans • Ensure CTMS, dashboards, and other systems are configured and available, including user acceptance testing • Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data, and timelines • Oversee CRA and Central Monitor resourcing, site assignments, conduct, and delivery risks • Review monitoring documentation and ensure timely delivery to company and sponsor specifications • Provide clinical deliverable and risk status updates to clients, project management, and leadership • Support inspection readiness, corrective action plans, data cut, and database lock deadlines • Provide performance feedback to line managers • Coordinate clinical activities across complex trials or portfolios • Coach and mentor CTMs on clinical delivery, project risks, and action implementation

🎯 Requisitos

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience • Demonstrated ability to lead and align teams in the achievement of project milestones • Demonstrated capability of working in an international environment • Demonstrated expertise in site management and monitoring (clinical or central) • Preferred experience with risk-based monitoring • Understanding of clinical trial management financial principles and budget management • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach • Critical thinking to determine causes and appropriate solutions • Moderate travel may be required, approximately 20%

🏖️ Benefícios

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate