Clinical Trial Manager II

🕒 Outubro 29

🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

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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 critical data, process and protocol execution risks and implement risk mitigations • Review study scope of work, budget and protocol content; ensure clinical project teams understand contractual obligations and parameters • Identify and escalate risks to timelines, quality and budget, including out-of-scope activities • Participate in and present at key meetings such as Kick Off Meetings • Serve as an escalation point for investigator site staff communications and interact with principal investigators and site staff by phone or in person • Coordinate delivery handoffs with Study Start Up, Patient Recruitment and Data Management to meet study milestones • 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 and access/audit trail reviews • Coordinate initial and ongoing study-team training on protocols, CRFs, dashboards, SOPs, plans and timelines • Oversee CRA and Central Monitor resourcing, site assignments and study-team conduct • Monitor quality and progress of clinical monitoring, central monitoring and site management deliverables using approved systems and tracking tools • Review oversight dashboards and clinical trial systems including CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS and central monitoring dashboards • Ensure assigned clinical team members understand and comply with monitoring strategies, CMP/SMP and risk plans • Review the content and quality of monitoring documentation and ensure timely delivery according to company and sponsor specifications • Provide client, project management and leadership status updates on clinical deliverables and risks • Collaborate with functional departments and support inspection readiness • Oversee CRAs and Central Monitors, assess compliance, identify emerging risks and support corrective action plans • Support activities to achieve data cut and database lock deadlines • Provide performance feedback to line managers • May be assigned to larger, more complex trials

🎯 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 • Good communication, presentation and interpersonal skills among project team and with sites • Strong conflict resolution skills • Ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to successful clinical research projects • Critical thinking to determine causes and appropriate solutions when identifying issues • 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 for employees or applicants with disabilities

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