Site Monitoring Lead, Germany

🕒 Agosto 28

🇩🇪 Alemanha – Remoto

⏰ Tempo Integral

🟠 Sênior

👻 Score fantasma 17%

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 post-activation through site closeout, including patient recruitment and investigator payments • Identify clinical trial management risks and develop or implement mitigations • Review study scope of work, budget, and protocol content; ensure CRAs/CeMs understand contractual obligations • Escalate timeline, quality, budget, and out-of-scope risks to the project manager • Participate in and present at key meetings, including Kick Off Meetings • Serve as an escalation point for investigator site staff communications and accompany CRAs to sites when needed • Coordinate with Study Start Up, Patient Recruitment, Data Management, and other functional leaders to meet study milestones • Develop and maintain clinical study tools and templates, including the Clinical Monitoring Plan • Ensure CTMS, dashboards, and other systems are configured and available; oversee UAT and access/audit trail reviews • Coordinate study-team training on protocols, CRFs, dashboards, SOPs, plans, data requirements, and timelines • Oversee CRA and Central Monitor resourcing, assignments, conduct, quality, and delivery • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards • Ensure monitoring strategy, CMP/SMP, and risk-plan compliance • Review site and central monitoring documentation and ensure timely delivery and appropriate risk communication • Provide client, project management, and leadership status updates on deliverables and risks • Support inspection readiness for clinical trial management activities • Oversee CRAs and Central Monitors, assess compliance, identify emerging risks, and support corrective action plans • Support activities required to achieve data cut and database lock deadlines • Provide performance feedback to line managers • Coordinate clinical activities for CTM teams on larger or more complex trials • 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 • Experience in oncology is an asset • 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 • Remote work (pre-approved)